#clinical trials remote jobs

[ccrpsorg]

Clinical Research Monitoring: A Guide to Clinical Monitoring

Clinical research monitoring is a vital part of clinical trials and it involves various activities to ensure the safety and accuracy of the data collected. It is important that the clinical trial is conducted in a way that meets regulatory standards, protects human studies participants, and minimizes potential risks to their health and well-being. Clinical trial monitoring can include activities such as auditing study sites, evaluating data for accuracy and completeness, review of protocols and amendments, reviewing case report forms (CRFs), identifying any deviations from the standard operating procedures (SOPs) or protocols, managing corrective action plans (CAPs), following up on safety reports, tracking progress against enrollment goals and much more. Apart from evaluating data quality, clinical research monitoring also ensures compliance with all regulatory standards like GCP (Good Clinical Practices) ICH (International Conference on Harmonization), FDA regulations and local laws. In addition to this ongoing monitoring throughout a study's duration, there may be audits conducted by sponsors or regulatory authorities at any time during or after completion of a clinical trial. All these efforts are dedicated towards ensuring that the results obtained from a clinical trial are accurate, reliable and applicable for use in making medical decisions.

Steps to Clinical Monitoring

1. Establish an Effective Monitoring Plan: Ensure that the plan is comprehensive and contains all applicable elements, such as the types of monitoring activities to be conducted, frequency of monitoring visits, data collection methods, and specific criteria for acceptable performance.

2. Develop Appropriate Documentation: Design protocol-specific monitoring tools and forms to document information from site visits including source documents, data collection instruments, case report forms (CRF). In addition, develop a Monitoring Log or Tracking System which will enable better accountability for study activities.

3. Execute Monitors’ Visits: Depending on the complexity of the trial and regulatory requirements, conduct pre-study qualification visits (PSQV), pre-initiation visits (PIV), initiation visits (IVs), periodic monitoring visits (PMV) and close out visits (COV). During each visit, ensure that good clinical practice is followed at all times by reviewing source documents and data collection instruments. Review patient enrollment logs to ensure accuracy and record any discrepancies in the visit report.

4. Report Findings: Generate detailed yet concise reports per each monitor's visit with clear recommendations for corrective actions if required; provide professional feedback to investigators regarding their performance; identify any areas of noncompliance with protocol requirements or applicable regulations; recommend training or educational sessions when appropriate; track all follow up activities related to corrective actions taken in response to findings from monitors' visits; ensure that essential documentation is complete before closing out a particular study site.

5. Quality Assurance: Validate accuracy of tracking systems used by monitors during their visits; assess risk associated with various deficiencies identified during monitoring process; carry out periodic internal audits/assessments to ensure compliance with established SOPs/guidelines related to clinical research monitoring activities; take preventive measures based on audit/assessment results in order to strengthen internal quality system processes.

Types of Clinical Trial Monitoring

1. Types of Clinical Research Monitoring: Clinical research monitoring is the process to assess the quality and integrity of clinical trial data and ensure compliance with applicable regulatory requirements. It can be done through three primary methods: onsite monitoring, centralized or remote monitoring, and risk-based approaches.

2. Onsite Monitoring: Onsite monitoring is considered the "gold standard" for clinical research monitoring, as it requires the presence of a monitor at a study site during the entire duration of a trial. The monitor will typically review source documentation such as patient records, lab results, and investigational product dispensing logs to assess accuracy and conformance with study protocols and good clinical practices (GCP). The monitor also interviews staff members responsible for conducting the trial to verify that procedures are being followed properly.

3. Centralized or Remote Monitoring in Clinical Trials: Centralized or remote monitoring enables sponsors to conduct clinical research monitoring without needing to send someone onsite to each study location. This is accomplished by using technology such as web portals, video conferencing, and virtual meetings that allow monitors to remotely review data from various sites simultaneously and quickly flag any issues that arise. Additionally, centralized/remote monitoring allows sponsors to be more proactive in identifying potential risks associated with a trial prior to sending monitors onsite for an assessment.

4. Risk-Based Approaches: Risk-based approaches use data analytics tools such as descriptive statistics and predictive algorithms to identify potential trends or outliers in clinical trial data that may represent heightened risk of noncompliance with GCPs or other regulations. By leveraging technology, these approaches can help sponsors identify issues earlier in the course of a trial so they can take corrective action before something goes wrong.

5. Benefits of Clinical Research Monitoring: Utilizing effective clinical research monitoring strategies helps ensure that trials are conducted ethically, safely, correctly according to protocol standards, within timelines agreed upon with regulatory authorities, and within budget constraints set out by sponsors/CROs/investigators/other stakeholders involved in a study’s execution.. Clinical research monitors act as an independent third party who are able to provide objective insight into how studies are being conducted across multiple sites which helps minimize errors due to bias from investigators or other personnel who may have vested interests in outcomes associated with their studies.. In addition, effective clinical research monitoring helps ensure patient safety by providing oversight about how drugs or medical devices used in trials are administered as well as ensuring patient confidentiality is maintained throughout the course of a study.. Lastly, robust clinical research monitoring protocols help reduce costs associated with delays caused by errors made during trials which can add up significantly over time if not avoided through proper oversight methods both pre-study start up until closeout occurs after all enrolled patients have completed their participation in a given trial

Clinical Research Monitoring Guide

1. Understand the Basics of Clinical Research Monitoring: Clinical research monitoring is a key part of the clinical research process, ensuring the safety and accuracy of results. It involves periodically assessing study sites to confirm that data is being collected properly, according to ethical and legal requirements, as per Good Clinical Practice (GCP) guidelines.

2. Know What Types of Studies are Monitored: Clinical research monitoring can be used for a variety of studies, including clinical trials, observational studies, epidemiologic studies, and public health surveys. It is important to know what type of study you are monitoring in order to ensure that the appropriate procedures are followed.

3. Understand How to Monitor a Study Site: The primary goal of clinical research monitoring is to confirm that the protocol and informed consent form have been followed properly at each site. This requires a thorough review of all relevant documents such as case report forms (CRFs), source documentation (e.g., physician notes), internal audit reports (audit trails), and external quality assurance reports. Additionally, it involves evaluating compliance with GCP guidelines during study visits or remote reviews, as well as conducting interviews with staff members to assess how they are handling data collection and reporting processes.

4. Become Familiar With Regulatory Requirements: In addition to GCP guidelines, there may be applicable regulations from local governments or other institutions that must be adhered to when conducting clinical research monitoring activities. Understanding these regulations is essential for ensuring compliance with applicable laws and regulations related to clinical research activities.

5. Develop an Effective Monitoring Plan: An effective monitoring plan should include a detailed timeline for visiting sites, information about any specific areas where focused attention is required (e.g., enrolling/randomizing patients or managing adverse events), and plans for auditing/reviewing data generated by the study site(s). Additionally, it should incorporate measures for controlling risk associated with data collection processes so that issues can be identified early on in the study process before they become problematic later on down the line.

Clinical Research Monitor Job

The job of a Clinical Research Monitor is to ensure that clinical trials are conducted ethically, safely and in compliance with established standards. The primary responsibility of the monitor is to protect the rights, safety and well-being of the human subjects enrolled in the trial. Duties typically include developing protocols for clinical studies; coordinating study start up activities; conducting site visits; monitoring data for timeliness, accuracy and completeness; auditing files for regulatory compliance; managing investigator queries/issues; preparing visit reports; reviewing update protocols related to study operations; resolving issues raised through audit reports or other sources; providing technical guidance to sites regarding protocol implementation or study conduct; and escalating complex issues or potential risks as needed.

Clinical Research Monitor Salary

Salaries for this position tend to vary depending on education level, experience and geographical location but can range from $60,000 per year for entry level positions up to around $90,000 per year for more experienced professionals. In addition to salary many employers also offer benefits such as paid vacation days, health insurance plans and retirement packages.

Resources for Clinical Research Monitoring

1. National Institutes of Health (NIH): Clinical Research Monitoring

This link provides information on NIH's guidelines for monitoring clinical research, which include topics such as the roles and responsibilities of the investigator, data safety monitoring boards, and protocols for reporting unanticipated problems and adverse events.

2. National Institutes of Health (NIH): Guide to Clinical Research Monitoring

This comprehensive guide walks readers through all aspects of clinical research monitoring, including topics such as study design, randomization strategies, regulatory compliance requirements, data management, monitoring plans and reports, quality improvement initiatives, and safety assessments.

3. US Food and Drug Administration (FDA): Guidelines for Clinical Trials Monitoring

This resource from the FDA outlines the importance of effective monitoring in clinical trials and provides an overview of the different roles within a clinical trial as well as details about essential elements for implementation of an effective monitoring strategy such as risk assessments and adverse event tracking.

4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

ICH has developed standards that provide a set of harmonized technical requirements for clinical trials conducted across countries in the European Union (EU), Japan, and US with an emphasis on quality assurance and safety monitoring during trials.

5. Association of Clinical Research Professionals (ACRP)

ACRP's guidelines provide best practice recommendations for conducting clinical research studies in accordance with applicable regulations and standards to ensure patient safety monitoring during studies as well as data integrity throughout the process from start to finish.

6. Pharmaceutical Research & Manufacturers of America (PhRMA)

The PhRMA guidelines provide an overview of expectations around clinical research activities with respect to ethics, data integrity, safety reporting, resource allocation and more. It defines roles and responsibilities of all those involved in overseeing a clinical trial such as a Clinical Research Monitor or CRA who has primary responsibility for ensuring that the protocol is implemented correctly throughout a study’s duration

Clinical Research Monitoring Review

1. What is the main purpose of clinical research monitoring?

A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards

B) To ensure that data collected during a research study is accurate and reliable

C) To evaluate the safety of participants enrolled in a research trial

D) To oversee the financial management of a research project

Answer: A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards. Clinical Research Monitors are responsible for ensuring compliance with Good Clinical Practice guidelines, protecting participant privacy, verifying data accuracy, and evaluating protocol deviations. In addition, they may also be involved in reviewing participant eligibility requirements, conducting site assessments, providing training to investigators and staff on proper study procedures, as well as monitoring progress towards completion of all requirements of the study.

2. What type of individuals typically serve as clinical research monitors?

A) Physicians

B) Nurses

C) Regulatory specialists

D) All of the above

Answer: D) All of the above. Clinical Research Monitors can come from various backgrounds such as medical doctors (MDs), nurses (RNs), pharmacists (RPhs), regulatory specialists (e.g., Regulatory Affairs Professionals or Paralegals), or biostatisticians/data analysts who have experience in clinical trials and understand local regulations related to human subject protection. Each monitor has specific job duties depending on their education and experience, such as assessing compliance with regulatory guidance or analyzing data sets for accuracy, completeness, integrity, or validity.

3. What kind of activities do clinical research monitors need to perform?

A) Protocol reviews or verifications

B) Ensuring appropriate documentation completion

C) Site visits to observe investigator conduct

D )All of the above

Answer: D )All of the above. Clinical Research Monitors need to perform several activities including protocol reviews or verifications; ensuring appropriate documentation completion; site visits to observe investigator conduct; liaising between sponsors and sites; assisting with resolving issues associated with adverse events; reviewing case report forms for completeness, accuracy, consistency and correctness; evaluating subject safety throughout enrollment process;and writing reports detailing their findings at each visit.

4. What is one benefit gained from having an effective Clinical Research Monitor on-site? A) Reduced risk for legal liability stemming from negligence

B) Improved protocol adherence by investigators

C) Increased patient engagement during trial period

D )All of the above

Answer: D) All of the above . An effective Clinical Research Monitor encompasses several benefits such as reduced risk for legal liability stemming from negligence due to thorough oversight and accurate record keeping; improved protocol adherence by investigators through continued communication between sponsor representatives and researchers on-site regarding best practices; increased patient engagement during trial period due to more detailed explanations about potential risks/benefits offered by having monitor on-site ; and improved efficiency when dealing with complex protocols that require multiple levelsof oversight due to familiarity with protocol specifics which decreases time spent troubleshooting errors or unclear instructions..

5. How often should Clinical Research Monitors visit a particular site?

A) Weekly B) Biweekly C) Monthly D) Quarterly

Answer: C) Monthly . It is recommended that Clinical Research Monitors visit sites at least once per month in order to maintain active surveillance over ongoing studies at each location while also providing timely feedback regarding any issues discovered while on-site visits are taking place within a shorter timeframe if needed based upon changes made midstream or other unanticipated circumstances which might require immediate attention by sponsor personnel.

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[stevenbasic]

Growing into the Job, Post 350: That was Then, This is Now, p2

“G-Gianna?” I asked Aubrey from my spot a foot off the floor, held aloft in Morgan’s strong hands, my bright colored shoes from the kids’ department dangling helplessly, “Wants to talk to me?” I gulped, trying my best to look dignified. Not an easy task. “N-now?”

I acted surprised, but I’d known this was coming. I’d had reports to complete, a bunch of data from the study to sign off on. It’d been tasked to me quite a while ago. As little as I actually really did for this thing, this clinical trial, Evolution relied on me and my authority to keep things on schedule. At least as far as my own paperwork was concerned, and this report had been due last night. 

“Yeah, she says now,” Aubrey replied, a funny look on her face as she  processed the scene in front of her eyes; the broadly smiling Uber-Amazon Morgan holding her shrunken boss like a toy, a boss that didn’t weigh very much, at that. Aubrey bit her lower lip before continuing. “And she sounds a little annoyed.”

“I am a little annoyed,” came a new woman’s voice, clear as day, from the speakers of my desktop computer. 

What the?? Looking to my left I saw, onscreen, the videochat window already open. There she was, Gianna, remotely controlling my computer. She was here with us already, sort of. I thought I’d told Marisela to fix that, not allow her access to- 

“Hi Morgan,” Gianna spoke, obviously able to see us as she remotely greeted the enormous blonde before me, “Can you put him in his chair so we can have a little talk?”

Next thing I knew I was being plopped behind my desk, butt-in-chair, facing the screen and an obviously nonplussed Gianna Albertini, Study Coordinator for Evolution Pharmaceuticals She was my liaison to the company and the face/ - holy crap look at her tits - chest behind all the money the practice was being infused with for its participation. She was young, she tended to be flippant about this whole project and my involvement, and she didn’t look happy.

After dropping me down into my seat, Morgan had stepped away, her big, long legs quickly getting her to the other side of my desk on her way to the door.

“Morgan, wait,”

Gianna’s voice stopped the big woman in her tracks. It spoke through my computer speakers, “maybe you can stay in the room with us as we chat.”

Morgan turned, with a smile, towering over my desk behind the terminal screen. “I can be doing that, yes,” she answered, with more than a small bit of excitement in her voice. Her smile widened, obviously enthused by the tone this conversation was taking. Even her teeth were big. I could see it already: she was looking forward to a dressing-down. Mine. A man’s at the hands of a woman with authority

Gianna regarded me through the camera. Her brow was crooked; she was not smiling. “Good morning, Doctor,” she spoke, “It’s been a bit since we last touched base, huh?” Though her tone was flat, I could see a glint of light in her eye as she regarded me even through our low resolution screens. She cocked her head. “You look hungry…and skinny.” she said, “Did you eat anything today?”

“N-no, I-” I actually hadn’t.

“Have one of those protein bars you keep in your desk,” she said, plainly. And then paused, waiting for me to act.

What the f-..? How did she know that? I thought, even as I found myself doing exactly as she’d suggested, opening the top drawer of my desk and pulling out a fruit-and-nut protein bar. Breakfast would probably be smart.

“You need the help to unwrap?” Morgan asked, from her looming position over my desk.

“No I-I got it,” I answered, peeling through the foil that - god help me - did give me more of a challenge than it should.

I took a bite. I’d thrown a few of these in here just last week but it still tasted old and stale, almost like the cardboard box they came in. A glass of milk might make it taste better, I couldn’t help but think.

“So, okay,” I began, between a few forced chews. I looked back at the screen trying my best to keep my eyes off her tits. “How long is this going to take?” I asked, “I have patients to get to.”

Gianna didn’t like that. “No, you don’t. I’ve had the staff move your morning patients to Morgan and Vida, because you’ll need the time for the report,” she said. She paused. “And, I don’t like your tone,” she added.

To that, I admit I bristled. Who was this woman, thinking she can run my day, my practice, my time with patients?! If you, dear reader, haven’t gathered it by this point, I was more than a little resistant to participating in this clinical trial to begin with. I was a little weirded out by the whole situation. Yes, the money was good for us - we actually needed it, with my reduced production - but I was not going to allow myself to be scolded by a corporate floozy behind a video chat screen. I was, however, smart enough not to say exactly what was on my mind…but I came exceedingly close. “Well, thanks for thinking of us, Gianna, but I have patient care as  my first priori-”

“I’m going to have to ask you to call me Ms. Albertini from now on….,” she broke in, her body language shifting onscreen - She set her shoulders and thrust out her ungodly chest - in a clear move  to show me who exactly was in charge. “...and I’m this close to demoting you from the principal investigator on this study and naming one of our girls instead.”

Okay, that was the last straw.

“What?!” I blurted, shocked by her boldness.

“You are late with the reports I needed from you, again. I’d given you plenty of time, and you’ve had more than enough warnings,” she laid into me, “I’ve tried to make this as easy for you as possible, because I know you have certain limits-”

“Limits?!?” I exclaimed, taken aback again by her attitude, her belittling of me. I know now, and I think I even kinda knew it then: that I was acting up, lashing out a bit irrationally. I think I felt the need to exert myself in some way, after all the humiliations and submissiveness I was starting to realize comprised my entire weekend. So it was here, I guess, that I was putting my foot down. “I’m perfectly capable of filling out the spreadsheets you need.” I started again, “I’m a busy person and this is-...this is just data entry. I frankly just need to find the time t-”

“Frankly you’re proving yourself to be just like other men,” she cut in, “and showing yourself incapable of the work.”

“Oh my god…!” I groaned, as I was vaguely aware of Morgan leaning a bit forward, over my desk. My hands shot up in impotent rage, but instead of jumping in with a defense of my beleaguered gender, my eyes suddenly drifted into Morgan’s massive, plump cleavage. Woof. A guy could get lost in there…

Morgan began to giggle, a deep and throaty chuckle as my anger began to slip through the cracks of my skull and I became lost in the vast swells of her chest.

Gianna took the opportunity - no doubt seeing my eyes dart upward - to lecture me on my sex’s many recent failings. Yes, yes, I knew that earlier this year women had become the majority of the workforce for the first time in U.S. history. Most managers, like Giana here, were now women too. All her bosses, the executives at the pharmaceutical company certainly were too, I was sure. She told me that for every two men who got their college degree this year, three women would be doing the same. The statistics regarding the graduate and professional degrees were even more dramatic. What do you think the workforce will look like soon? she asked me, Do you think society won't change because of this? For years, decades, generations, women’s progress had been cast as a struggle for equality. “But what if we know now that equality shouldn’t be the end point?” she asked me, as the blonde giantess Morgan continued to keep me tempted  by her big Hungarian bosom. “What if modern society is simply better suited for women like me and Morgan, and Melissa and Olivia and Lakshmi and all the others, to dominate it? To run the lives of flawed, frail men like you?” 

My heart was pounding. Was it fear or, god help me, was I turned on?

Men had been the dominant sex since, well, the dawn of forever. It was called ‘mankind’ for a reason, right? But I knew that, for the first time in human history, that was all changing - and it seemed to be doing so with shocking speed. Cultural and economic changes always reinforce each other, so - yes, like Gianna said - society was certainly going to be different with more and more women becoming the breadwinners, the business leaders, the politicians and even the clergy. Home life was also certainly going to change. With more husbands becoming  dependent on their wives, if there was a ‘Battle of the Sexes’ imminent, like so many were predicting, would they be forced to 'bend the knee' to the so-called superior gender. What would happen to what we considered democracy? What we considered America?

And, it wasn’t just here in the US. The global economy was evolving in new, unexpected ways as well. Many countries were seeing the historical preference for having male children begin to erode. Gianna began talking about  using new advances in medical technology to purposefully alter the birthrates of each sex. She wasn’t just talking about doing it abroad, but here at home as well. The thought made me squirm. Was I outraged? Disturbed? Excited? I didn’t know.. I was far too captivated by Morgan’s chest to understand even my own feelings.

“Oh my god, just look at you,” Gianna said, finally calling me out as I stared blankly forward clearly hypnotized by Morgan’s massive tits. She smirked with a knowing smile that mirrored Morgan’s own. “This is totally going to be how it happens, you know, ‘The End of Men’. You’re all just going to give in to your pathetic male urges and slowly fade away into our cleavages. Battle of the Sexes? We won’t have to fight you at all.”

“F-fight?” I said, confused. I was - I really was! - trying to be angry, trying to resist. But I knew I was instead coming across as pathetic and weak. I clearly, obviously, didn’t really care about my position here, my authority. I only cared about how fucking hot this was though inside my logical side wanted to be enraged and rebel. I was turned on more and more every moment, with every belittling comment Gianna lobbed my way. Regardless of what I said, it was obvious that I was exactly where they wanted me. They knew I would fall into line. Maybe I already had.

Gianna, though, had worked herself into an animated fervor, and she was very obviously still pissed. “I can’t wait, I really can’t,” she began again, “for this study to be fucking done with so I can get out of quarantine and get a hive of my own!”

What? What was she talking about?

“I want to start flexing,” she continued, now sounding like she was talking to herself as much as she was addressing me or anyone else. “I’m a fucking queen and all I have to show for it so far are these enormous tits.”

“wh-what do you m-?” I asked, obtusely. I really had no idea, dear reader, what was going on.

“Oh, don’t pretend you don’t realize,” she pressed on, speaking over me, “how every girl around you has been busting through their bras, just to give you more to look at? Even me. Even just being on these fucking video chats with you has done this…”

At that, onscreen, Gianna turned in profile, pressed forth her shockingly big chest, and nearly gave me an aneurysm. 

“It’s you, you little fucker, you little boob monkey,” she chastised, turning back to the camera, “You’re the one doing this to us.”

“Wh-what??” I stammered, more confused than ever. Is this woman crazy? What’s she talking about??

She continued on her rant, speaking quickly, in heat. “Yep I was assigned to you and surprise surprise what makes me best at getting you to do what I need?” At that, she cupped her hands under her giant breasts and lifted them, bouncing them up and down, flesh quivering above her neckline. “These. You’re the one male I’m allowed to talk to and I guess I shouldn’t be surprised. We knew you were a tit-obsessed freak. I just can’t believe I’m so fucking attracted to you now, either. You’re fucking perfect, so small and weak.”

I was sputtering, confused, still trying to be angry and definitely weirded out by the delusions of this woman, but finding it hard - god help me - to argue back when a set of tits like that just told me I was cute. But, I knew I needed to somehow get this meeting out of its bizarre tailspin and was about to speak up again when Gianna asked for the blond behemoth again. 

“Morgan, sweetie, can you pull his desk out of the way?” she queried, “Just make sure he can still see his computer.”

“Of course,” Morgan answered and then suddenly - sweet lord - with the ease of someone pulling the sheets off the bed she’d yanked my desk back away from me, just enough so, now that she’d stepped back around, she had room to squeeze in, crouch down between my legs and with one hand on each of my knees spread my legs. And she had, yes, repositioned my screen so Gianna could watch this whole thing and - more importantly for her, I think - I could see her. 

“I obviously need you to imprint on me a bit,” Gianna explained through the speakers, adjusting her low-cut blouse and my view of her tits as Morgan looked up into my eyes and seemed ready to just pull the thin fabric of my scrub pants off me. With the same strength she’d shown with my desk, my pants could come off like tissue paper. I knew I’d be in her mouth in seconds. Morgan smiled, grabbed the fabric of my scrubs at my thighs, and slowly started to tear them away when suddenly we were interrupted.  

“Knock knock,Sweetie,” an angelic voice came from the doorway, “I’ve got you your milk…”

Melissa. 

===============================================

thanks to RiF again for his help editing and inspiring.

Here there be more:

#growing into the job

[sudheervanguri]

Join Thermo Fisher: Safety Writer vacancy in Clinical Research (Remote) Thermo Fisher Scientific, a global leader in scientific research and innovation. We are currently offering remote opportunities for Safety Writers who are passionate about contributing to the field of clinical research. Join us in ensuring the safety and well-being of patients globally while working in the comfort of your home. About Thermo Fisher Scientific Inc: Thermo Fisher Scientific is at the forefront of scientific breakthroughs, committed to enabling our customers to make the world healthier, cleaner, and safer. With a rich history of innovation and a culture rooted in excellence, we strive to make a positive impact on society through our contributions to the scientific community. Thermo Fisher Scientific Vacancies: Explore the following exciting position currently open for application: Position Title: Safety Writer Location: Remote, India Job Type: Full-time Category: Clinical Research Remote: Fully Remote [caption id="attachment_60743" align="aligncenter" width="1200"] Join Thermo Fisher: Safety Writer vacancy in Clinical Research (Remote)[/caption] Job Description: As a Safety Writer at Thermo Fisher Scientific, you will play a pivotal role in planning, coordinating, and delivering safety writing services for clinical trial and/or marketed product projects. Your responsibilities will include conducting data review, authoring low to medium complexity safety writing deliverables, and collaborating effectively with project teams and clients within a highly regulated pharmacovigilance environment. Qualifications and Requirements: Education Background: Bachelor's degree or equivalent Experience: 2+ years Skills and Abilities: Good knowledge of ICH and US aggregate safety reporting formats, attention to detail, critical thinking, effective communication, and proficiency in Microsoft Office products. How to Apply: If you are ready to contribute to groundbreaking scientific advancements from the comfort of your home, apply now! Apply online

[industry212]

What are remote data science jobs to apply for in March 2024?

In March 2024, the field of data science continues to offer a plethora of remote job opportunities across various industries. As technology evolves and businesses increasingly rely on data-driven decision-making, the demand for skilled data scientists remains high. Here's a glimpse into some remote data science jobs you might consider applying for in March 2024 and Big Data

Machine Learning Engineer: Machine learning engineers are in high demand as organizations seek to leverage artificial intelligence and predictive analytics to gain insights from their data. Remote positions in this field often involve developing and deploying machine learning models, optimizing algorithms, and collaborating with cross-functional teams to integrate ML solutions into products or systems.

Data Analyst: Data analysts play a crucial role in interpreting and analyzing data to inform business decisions. Remote data analyst positions typically involve querying databases, cleaning and preprocessing data, performing statistical analysis, and creating visualizations to communicate findings effectively. These roles are prevalent across industries such as finance, marketing, healthcare, and e-commerce.

Data Scientist: Data scientists utilize advanced analytics techniques to extract meaningful insights from complex data sets. Remote data scientist positions may involve tasks such as predictive modeling, clustering analysis, natural language processing, and experimentation. These professionals often work closely with stakeholders to identify business opportunities and develop data-driven solutions.

Quantitative Analyst: Quantitative analysts, also known as quants, apply mathematical and statistical methods to financial and risk management problems. Remote quant roles typically involve developing and testing trading strategies, building financial models, and conducting quantitative research to optimize investment decisions. Strong programming skills and proficiency in quantitative analysis tools are essential for these positions.

Business Intelligence Developer: Business intelligence developers design and implement solutions for gathering, storing, and analyzing business data. Remote BI developer roles may involve designing data warehouses, creating dashboards and reports, and implementing ETL (extract, transform, load) processes. These professionals collaborate with stakeholders to understand reporting requirements and deliver insights that drive strategic decisions.

Data Engineer: Data engineers focus on designing and maintaining the infrastructure required for data storage, processing, and retrieval. Remote data engineering positions often involve building data pipelines, optimizing database performance, and implementing data integration solutions. Proficiency in big data technologies such as Hadoop, Spark, and Kafka is typically required for these roles.

Statistical Programmer: Statistical programmers play a critical role in analyzing clinical trial data and supporting research projects in the pharmaceutical and healthcare industries. Remote statistical programming positions involve programming and validating statistical analysis code, generating tables and graphs, and ensuring compliance with regulatory requirements. Knowledge of programming languages such as SAS, R, or Python is essential for these roles.

AI Research Scientist: AI research scientists focus on advancing the state-of-the-art in artificial intelligence through theoretical research and experimentation. Remote AI research positions may involve developing new algorithms, conducting empirical studies, and publishing research findings in academic journals or conferences. These roles often require a strong background in computer science, mathematics, and machine learning.

Data Science Consultant: Data science consultants work with clients to solve complex business problems using data-driven approaches. Remote consulting positions may involve conducting needs assessments, developing custom analytics solutions, and presenting findings to stakeholders. Strong communication and project management skills are essential for success in these roles.

Freelance Data Science Projects: In addition to traditional full-time roles, many companies and organizations offer remote freelance opportunities for data scientists. Platforms such as Upwork, Toptal, and Kaggle allow data scientists to bid on projects ranging from data analysis and visualization to machine learning model development. Freelancing offers flexibility and the opportunity to work on a diverse range of projects.

In conclusion, March 2024 presents a wide range of remote data science job opportunities across various industries and specializations. Whether you're interested in machine learning, data analysis, or business intelligence, there are plenty of remote roles available for skilled data professionals. Keeping an eye on job boards, networking with industry professionals, and leveraging online platforms can help you find the perfect remote data science job to apply for and Stock Prices and News

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[altairibnlasalad]

5 Factors Why ICT Is Actually Critical In The Healthcare Industry

ICT plays a crucial task in changing the healthcare market, transforming the way clinical specialists supply care and individuals gain access to companies.

Listed Below Are Actually Five Powerful Factors Why ICT Is Actually Important In The Health Care Field:

Effective Patient Care Management

The Zorg ICT assists in effective person care management via the application of electronic wellness documents (EHRs) and wellness information systems. These modern technologies enhance the storage and retrieval of patient information, guaranteeing that medical care providers possess easy accessibility to exact and detailed records. This advertises better-informed decision-making, reduces the risk of health care errors, and boosts total patient care high quality. Moreover, electronic documents permit smooth communication among different doctor, bring about strengthened care balance.

Telemedicine and Remote Patient Monitoring

The assimilation of Zorg ICT has actually paved the way for telemedicine and remote individual monitoring, making it possible for medical care companies to extend beyond typical medical clinic environments. Telemedicine allows people to seek advice from along with medical care professionals from another location, boosting accessibility, especially for individuals in remote or even underserved places. Remote individual monitoring, enabled through wearable devices and IoT (Internet of Things) technologies, permits doctor to track people' essential indications and health signs in real-time, bring about positive assistances and individualized treatment programs.

Records Analytics for Informed Decision-Making

The healthcare sector creates large volumes of data, varying coming from patient reports to clinical trial results. ICT inspires health care experts to harness the ability of this records by means of advanced analytics. Large data analytics and machine learning algorithms may find valuable understandings coming from big datasets, assisting doctor create more knowledgeable decisions. Anticipating analytics may assist in pinpointing possible episodes, enhancing resource allocation, and tailoring treatment strategies based upon historic records, essentially strengthening patient end results.

Improved Communication and Collaboration

ICT tools facilitate smooth communication and partnership amongst healthcare experts, bring about improved client care. Electronic communication platforms, secure messaging systems, and teleconferencing tools permit medical care crews to team up in real-time, despite physical proximities. This is actually especially crucial in complex cases that call for input coming from multiple specialists or when prompt choices are crucial. Improved communication likewise reaches client engagement, as ICT enables medical care providers to share pertinent information along with patients, fostering an even more active job in their very own health care management.

Improved Healthcare Accessibility and Outreach

ICT in health care provides to breaking off down geographic barriers, making healthcare services even more obtainable to a bigger populace. Mobile health and wellness apps, online consultations, and health information gateways encourage people to proactively handle their health and wellness. In addition, outreach programs may utilize ICT to disseminate information regarding safety nets, inoculation campaigns, and hygienics efforts. By utilizing the power of ICT, health care institutions may reach varied communities, market health and wellness recognition, and result in general populace welfare.

Lastly, the integration of Information and Communication Technology in the health care sector is actually certainly not merely a technical advancement but a fundamental change that boosts individual care, improves effectiveness, and supports far better wellness results. As the health care landscape proceeds to progress, ICT will certainly participate in a progressively vital part fit the future of health care delivery and management.

#ICT

[datascraping001]

Psychiatrist Email List

Datascrapingservices.com - Your Gateway to Success with Psychiatrist Email List. The field of psychiatry plays a crucial role in promoting mental health and well-being, addressing a range of emotional and psychological challenges faced by individuals. For psychiatrists and healthcare organizations, effective communication with colleagues and potential clients is essential. Datascrapingservices.com understands the significance of building strong networks in this field and offers a valuable resource - the Psychiatrist Email List. In this article, we'll explore the immense potential of this email list and why Datascrapingservices.com is the ultimate source for connecting with psychiatrists.

1. Precision Targeting: The Psychiatrist Email List provides direct access to a highly targeted audience of psychiatrists. Whether you're a healthcare professional seeking collaboration or a healthcare marketing company looking to promote services, precision targeting is essential.

2. Improved Networking: Forge professional connections within the field of psychiatry. Collaborate with fellow psychiatrists, mental health professionals, and healthcare organizations to share knowledge and stay updated on the latest industry developments.

3. CME Opportunities: For organizations offering Continuing Medical Education (CME) courses or events, the email list is a goldmine for promoting your programs to a relevant and engaged audience.

4. Telehealth Services: With the growing importance of telehealth, the Psychiatrist Email List can help telehealth platforms and services connect with psychiatrists interested in providing remote care.

5. Research and Clinical Trials: If you're involved in psychiatric research or clinical trials, the email list can help you identify potential participants and collaborators.

6. Career Advancement: For psychiatrists seeking new career opportunities or those interested in advancing their careers, the email list can be a valuable resource for job openings and networking.

Datascrapingservices.com is a trusted source for high-quality data services. We are committed to providing accurate, up-to-date, and reliable data to empower healthcare professionals and organizations alike. Our Psychiatrist Email List is meticulously curated to ensure that you have access to the most valuable and relevant contacts in the field of psychiatry.

Best Email List Provider

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In the ever-evolving field of mental health and psychiatry, connecting with the right professionals is vital. Datascrapingservices.com's Psychiatrist Email List empowers healthcare professionals, healthcare organizations, and healthcare marketing companies to enhance their networking, research, and marketing efforts. If you're looking to strengthen your network within the field of psychiatry or promote healthcare services to a targeted audience, reach out to Datascrapingservices.com to learn more about how our Psychiatrist Email List can transform your approach and help you achieve your professional goals. Your connections and healthcare initiatives deserve nothing but the best, and Datascrapingservices.com is here to provide it. Contact us at [email protected] and unlock the potential of your psychiatric network today.

Website: Datascrapingservices.com

Email: [email protected]

#psychiatristemaillist #psychiatristsmailinglist #emaillistscraping #emaillistprovider #datascrapingservices #webscrapingservices #webscrapingexpert

[earnmoney77]

10 Easy Way Of Making Money

It's important to approach the idea of making money with a realistic and ethical mindset. There are no guaranteed "easy" ways to make money, but there are legitimate ways to explore opportunities and work towards financial goals. Here are a few ideas to consider:

Freelancing: If you have skills in writing, graphic design, programming, digital marketing, or other areas, you can offer your services on platforms like Upwork, Freelancer, or Fiverr. Clients pay for the work you provide.

Online Content Creation: If you enjoy creating content, you could start a YouTube channel, a blog, a podcast, or even an Instagram account. As your audience grows, you can monetize through ads, sponsorships, and merchandise.

Online Courses and Ebooks: If you have expertise in a specific field, you could create and sell online courses or ebooks. Websites like Udemy and Teachable can help you set up and sell your courses.

Affiliate Marketing: By promoting products or services through affiliate programs, you can earn a commission on sales generated through your referral links. This can be done through blogs, social media, or websites.

Stock Photography and Videos: If you're skilled in photography or videography, you can sell your work on platforms like Shutterstock or Adobe Stock.

Dropshipping or E-commerce: Setting up an online store and selling products can be a way to make money. With dropshipping, you don't need to hold inventory; products are shipped directly from suppliers to customers.

Rental Services: If you have assets like a room, property, or even a car, you could consider renting them out on platforms like Airbnb or Turo.

Remote Work: Many companies offer remote job opportunities in various fields. You can find these on job search websites like LinkedIn, Remote.co, and We Work Remotely.

Tutoring or Online Teaching: If you're knowledgeable in a particular subject, you can offer tutoring or teaching services online through platforms like VIPKid or Chegg.

Participating in Research Studies: Universities and research institutions often pay participants for taking part in studies, whether they are online surveys, product testing, or clinical trials.

Remember, while these ideas can potentially generate income, success usually requires effort, time, and dedication. Be cautious of any opportunity that promises quick and guaranteed riches, as it's often too good to be true and might lead to disappointment or even scams. Always do thorough research before committing to any money-making endeavor.

#money #make money online #make money from home #earn money online #profit #income

[9kmovies-biz]

Remote Senior Product Manager Job at Curebase -Jobsclub

About the role As the most flexible decentralized clinical research solution, Curebase’s software platform lets anyone, anywhere participate in clinical trials. We are seeking a results-oriented, data-driven Senior Product Manager who will thrive in a quickly scaling healthcare technology environment. Product management at Curebase is deeply collaborative, and you will work with nearly every…

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[igcpsas]

Best Institute for SAS Training Course in Hyderabad

IGPC are leaders in advanced training that provide the best SAS training course in Hyderabad. Clinical SAS is a program used in medical research industries, pharmaceutical companies, & b-tech companies for conducting clinical trials. Great speed & efficiency can be achieved with the use of Clinical SAS in conducting clinical trials & help eliminate risks. The software helps professionals to analyze clinical data more efficiently & break down the complex data generated from clinical research into simple graphical & statistical representations, further, it also helps the researchers to uncover hidden insights & these professionals structure the unstructured data, making it easy to read & understand for framing better clinical trials in the future.

The clinical SAS is the only software program available that generates reports using CDISC standards like SDTM & ADAM as the FDA only accepts SAS reports, it makes a significant difference as all the pharmaceutical & biotech industries use the SAS program for conducting clinical trials. The clinical SAS software holds a lot of capabilities, & students who wish to pursue a career in learning clinical SAS can have a bright future, earning a handsome income & gaining expertise in the field. Joining the best clinical institute in Hyderabad can help me master the clinical SAS programming software.

Best Clinical Training Institute in Hyderabad

IGPC provides students with the best SAStraining course in Hyderabad, with many features, such as quality syllabus & certification. Our certified students have been able to land some of the highest-paying jobs in the field of clinical SAS. We provide students with a wide range of services when it comes to learning clinical SAS & educating themselves to become one of the best learners.

Interactive Sessions

IGPC provides students with a session of interactive sessions where students interact with the trainers \ teacher & other students. A series of questions & answers are followed in our sessions, we also connect students to our ex-students for a question & answer round so all our current batch can learn from the previous batch that has landed a successful job in the field of Clinical SAS.

Online Clinical SAS Training Course

IGPC provides students with an online SAS training course in Hyderabad, & also connects students from remote or distant parts of India for the training course. Our online courses are highly interactive & help students from remote to learn better & have a quality education. We also provide distant students with certification of the entire SAS course along with mock tests, & online examinations.

Flexible Timings

Most of the students that enroll for our SAS training courses in Hyderabad are mostly working or pursuing future education. Making it a challenge to side hustle & pursue a SAS training program, therefore we provide our students with flexible timings where they can choose the batch they want, & which fits into their daily schedule. Flexible timings help our students learn better.

Affordable Course Fees

At IGPC we understand that most of the students that enroll with us are either working for their families or earning a living for their future. Our course fees are highly affordable, we provide students with customized course plans based on expertise & duration. From beginner to advanced courses we have different planned courses classified on basis of duration & pricing. We also provide students with scholarships & installment payments for our courses.

SAS Course Certification

We IGPC provide every one of our students with certification on the completion of the SAS clinical course. Our certified students have been able to land jobs at top pharma companies & medical research centers. We provide students with grades based on their performance in the examinations, our final certification includes the grades of the candidates.

Why IGPC For SAS Clinical Training

IGPC is the best clinical SAS training institute in Hyderabad, which provides a wide range of educational services related to clinical SAS learning. We provide students with the most complete SAS training course in Hyderabad, which is affordable & a good return on investment for students who what to pursue a career in clinical SAS. Other educational facilities such as scholarships & paying in installments are also available with IGPC. We help students learn & educate themselves better. IGPC also provides students with mock tests, examinations, syllabus, books, assignments, connection to teachers, internet facilities, real-time examinations, case studies related to clinical SAS & also with final certification on completion of the training program. Feel free to connect with the best SAS clinical institute in Hyderabad, IGPC today for enrollment & admissions.

#best SAS clinical institute in Hyderabad #SAS training course in Hyderabad

[fireflyskitters]

Almost Four Months in Taipei

I’ve been here in Taipei for four months and it’s almost the end of the year, so I guess some reflection is warranted. Normally, I reflect a lot–excessively, to the point of getting too hung up and being counterproductive–but I’ve had so little free time that it feels like I’m jumping from one activity to the next, from work to classes then chores and meeting people. In fact, I’m only able to write this now because I’m sacrificing some of my work hours (which is making me sound like a workaholic).

To put things into perspective, the pandemic felt like the worst two years of my life, and my time in Taipei so far has been the best few months. The pandemic was horrible because I got stuck with my family for two years with very little independence–I had to depend on my mom to drive me, couldn’t see anyone else, and frequently struggled with the nagging sense that I was wasting my mid-20’s away. My mid-20’s just seem like a blank period to me now–I went into the pandemic at around 24, then went out of it at the end of being 26. But as shitty as it felt, I don’t have any regrets about it because it forced me to grow up (learn how to be disciplined with work, how to save money, how to cope without external distractions). It also allowed me to spend time with my grandfather, who’d asked me then if I couldn’t stay with them forever so they would have company. Without the pandemic, I don’t think I would have been able to say goodbye to him properly, and just for that reason alone–being with my grandfather during his final years–I can say that all of it was worthwhile.

Taipei has been the best few months because–I feel accepted here? It’s not even about moving to a more developed country–I’d stayed in Singapore and US before for a while, and I didn’t really feel strongly about them. I suppose in Taipei, so many of the things that I like and am deeply interested in are validated, versus back home where I felt so out-of-place with them.

One is learning Chinese. My family was constantly griping at me about putting so much effort into it (“why not learn a European language? who cares about Chinese?”), and most people saw it as a quaint curiosity. But here, I sit for two hours every day with a teacher and other students who care about the language. I went for a hospital checkup the other day, and the doctor sacrificed a few minutes of his time to share a website with ancient Chinese texts, telling me to read them someday. My language exchange partner slash friend teaches classical Chinese. People regularly tell me, 加油, which in English can be translated as a variation of “Good luck!” or “Work hard, keep trying!” As someone whose interests were constantly being invalidated, it feels so nice to be connected to what I’m learning.

Second would be the remote work / digital nomad lifestyle. When I talk to my peers back home, their lives always seem to revolve around their nine-to-five job, and often in unfavorable ways. This might be more of a PH thing¬–my online friends from other countries don’t really seem to be like this. But here, I’ve met plenty of people who have less traditional careers or paths in life. For example: a guy who used to work as a product manager for a US tech company, but then he got a special visa in Taiwan for high-income earners, so he quit his job, relocated here, and travels around freely now. A girl who works as a clinical trial manager for J&J but squeezes in enough time to solo travel. A friend from Spain who does part-time marketing for a finance startup while taking Chinese classes. When I talk to them, what I do feels normal, and they’re also showing me what I want to be in the future. I don’t… feel so different.

That’s not to say I’m idealizing Taiwan–I can barely speak the language well enough, my friends here are all English-speaking–because there are a lot of things that I miss about PH. The unbeatable convenience of Grab (you can pretty much order anything from the app). Apartments with elevators and security guards¬–I have to walk up five floors to my apartment here every time. Mostly cashless payments rather than having to give cash to my landlord every time. European food that tastes decent and isn’t overpriced. Being able to cook (I’m dreading the consequences of all of the vegetable oil that my food is soaked in here). Having free time because I was mostly focused on work back then. Wearing dresses and tank tops (for some reason, people don’t wear sundresses as much here, even in summer). Maybe so many more things that will only hit me the longer I stay here.

I guess I can also count it as a turning point in my life because it’s the first… authentic achievement I’ve had in a very, very long time? I started out as an overachiever kid who didn’t really care about what she was studying, then lost my motivation after that because I was so confused about which direction I wanted to go in–I think I always knew, but my mother kept forcing me into programs and environments that really didn’t fit me as a person. Staying in Taiwan was an actual dream of mine. I’m still not sure how I made it work, but everything aligned. I got a scholarship for a few months which gave me an entry point, my remote job took off and it’s with a language learning app so this is helping my career, and once I got here, it was feasible–although a bit exhausting–to keep staying and working. But the fatigue is worthwhile because I’m following a dream.

So for the first time in a long time, I can say that I’m proud of myself.

[website-content-writers]

Clinical Trial Transparency Medical Writer - Synterex - Boston, MA

Clinical Trial Transparency Medical Writer – Synterex – Boston, MA

Experience and skilled performing medical literature searches. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate,…From Synterex – Fri, 02 Dec 2022 03:30:55 GMT – View all Boston, MA jobs Continue to Job Details. Go here for more writing and editing jobs.

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#technicalwritingjobs #techwriting #writingjobs #Technical Writing Jobs Remote

[fanyajob]

Clinical Trial Manager (Sponsor Dedicated) - Work from Home / Remote

Clinical Trial Manager (Sponsor Dedicated) – Work from Home / Remote

Job title: Clinical Trial Manager (Sponsor Dedicated) – Work from Home / Remote Company: IQVIA Salary: () Location: Reading and that all work is accomplished with quality and in accordance with sponsor Values IQVIA is a leading global provider of advanced… Apply for the job now!

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[fiorick]

Associate Principal Scientist, Statistical Programmer | Oncology (Remote)

Associate Principal Scientist, Statistical Programmer | Oncology (Remote)

Job title: Associate Principal Scientist, Statistical Programmer | Oncology (Remote) Company: Merck & Co. Job description: we are … We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than…, statistical analysis and high-quality data to support decision making in clinical trials. The Associate Principal Scientist… Expected…

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#job in united states

[sudheervanguri]

Parexel, a global leader dedicated to improving the world's health through cutting-edge clinical development solutions. From clinical trials to regulatory, consulting, and market access, Parexel is driven by a shared goal - a deep conviction in improving patient outcomes. Join us in making a difference and contributing to the development of therapies that positively impact lives. Position Title: Associate Medical Writer Company Name: Parexel Salary: Competitive, based on experience Company Address: India-Chandigarh-Remote Time Type: Full Time Job Requisition ID: R0000017552 Detailed Job Description Role: Associate Medical Writer Under departmental supervision, you will be responsible for the management of scheduled and unscheduled aggregate reports, including but not limited to: Periodic Safety Reports (PSRs) Periodic Safety Update Reports (PSURs) Periodic Benefit-Risk Evaluation Reports (PBRERs) Addendum to Clinical Overviews (ACOs) Semi-Annual Safety Reports (SASRs) United States Periodic Adverse Drug Experience Reports (PADERs) Development Safety Update Reports (DSURs) Risk Management Plan (RMP) Safety Statements Health Hazard Evaluation (HHE) Drug Safety Report (DSR) Clinical Overview (CO) Safety Evaluation Report (SER) Investigational New Drug Annual Report (INDARs) You will also be involved in preparing documents comparing local and global labeling documents, checking International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements, and participating in signal detection and management activities as applicable. APPLY ONLINE

[ccrpsorg]

Virtual Clinical Trial

Clinical Research Remote Summary

A new method of collecting safety and efficacy data from clinical trial participants to from study start-up through execution. The trial takes full advantage of technologies and online social engagement platforms to conduct each stage with the comfort of the patient.

The COVID 19 pandemic has rapidly challenged the pharmaceutical industry to implement remote clinical research. The industry lacks extensive experience with distant methods of clinical trials. The opportunity for the remote clinical trial has been recognized for some time. The industry is making indoors with this operational paradigm. Remote data collection will not be feasible for all types of measurements. A decision tree should be defined to identify which clinical measure translates to candidate remote measurement. Regardless of the clinical to remote measurement pathway taken, several activities are required to ensure that the remote data that is collected is safe, usable, and valid. Attention must also be given to measurement frequency and schedule assessment for remote measurement. Many connected devices that can measure data can record it continuously. Collecting clinical trial assessment in remote mode is different and have their advantages as well as disadvantages.

  FDA guidance on remote monitoring 

FDA plays a crucial role in protecting the united states from threats such as emerging infections including pandemics such as coronavirus. FDA is issuing this guidance to provide general consideration to assist sponsors in assuring the safety of participants, maintains compliance, and minimizing risk to trial integrity. FDA guidance on the conduct of the clinical trial of the medical product during COVID-19 pandemic is important, in case to know about the drug safety or proper usage.

The progress of adopting a decentralized clinical trial model and remote data collection was limited before the COVID-19 pandemic. However, the rapid adoption of telehealth during COVID-19 when the remote doctor visits become vital. Remote monitoring clinical trials during COVID-19 become crucial. The rapid rate of adoption to remote measurements and sharing the experience and results can accelerate the field of clinical trials. During COVID-19 pandemic, many details still need to be figured out regarding remote monitoring. However, the current situation could be an opportunity to revamp the conventional clinical trial models.

   Virtual clinical trials can satisfy the need for vigorous clinical trials by using distributed technologies. Virtual clinical trials can reduce cost, shorten trial timelines, increase protocol adherence, and boost recruitment members and participants diversity. These trails provide access to the participant to the research team through a technology’s web portal. Although complete development regarding the collection of a lot of data. This approach holds growth potential. It is also critical in the social component of clinical trials along with the trust that can develop between participants and researchers. A VR based communication hub for VCT should reinsert some human of elements to these studies Use of VR to support interpersonal relation between participant and researchers are important for the single-blind study.

 . 

References: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency - FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/ - Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/ - Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6969384/ - A Virtual Home for the Virtual Clinical Trial https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051945/ - Conducting a Virtual Clinical Trial in HER2-Negative Breast Cancer Using a Quantitative Systems Pharmacology Model With an Epigenetic Modulator and Immune Checkpoint Inhibitors

#clinical research remote #clinical trials remote jobs #fda guidance on remote monitoring #remote monitoring clinical trials #remote monitoring clinical trials covid #fda guidance on conduct of clinical trials of medical products during covid-19 pandemic #remote monitoring clinical trials sop #virtual clinical trials #fda guidance remote consent

[soaringthroughthegalaxy]

Masterlist

My inbox is open and I'm taking requests.

Please note that I do not take smut requests - saucy/sensual/lil' spicy is fine, but things will fade to black before it gets too hot and heavy.

Mainly write for our dear Batch boys, but expanding out into the realms of Rex, Fives, etc.

Need some request inspo? Check out my prompt list.

Masterlist below the cut.

Key:

Fluff - 🧸

Romantic - ❤️

Smut/NSFW - 🫦

Whump - 😢

Requests - 🔔 

Tech

Trial and Error 🧸❤️ F!reader / 4.7k / Left alone with the brainiest of the Batch after another successful mission, you find that there's one subject he's not an expert in.

The Next Step ❤️🫦 F!reader / 5k / Being stuck on Mount Tantiss gave Tech plenty of time to think, and now that he’s been rescued, he wants to take the next step with you.

Keeping Vigil 😢 GN!reader / 1.2k / The little clinic on Pabu isn’t much, but you won’t leave it until he wakes.

Token of Affection 🧸❤️🔔 F!reader / 2k / They say actions speak louder than words. When you unexpectedly join Tech in the cockpit, your presence unravels the intricate emotions he's been struggling to convey.

Hunter

A Quiet Place to Rest 🧸 F!reader / 1.1k /  It's hard to sleep during thunderstorms, especially with enhanced senses.

Family Planning ❤️🫦 F!reader / 2.6k / Life slows down once everyone is safely back on Pabu, and maybe now it’s time to start focusing on what you both want for the future.

Green Doesn’t Suit You ❤️🫦🔔 F!reader / 6.5k / With the whole squad safely back on Pabu, you settle into a comfortable civilian life. But the yearly Celestialis festival, said to bring good fortune for the next year to those who attend, brings with it something you never thought you’d have.

Be Mine ❤️🫦 F!reader / 1.8k / Falling into bed with the handsome Sergeant hadn't been on your bingo card. Then again, falling in love with him certainly hadn't been either.

Safe with You ❤️🫦🔔 F!reader / 2.6k / After you were snatched by locals on a recent mission, buried feelings bubble up to the surface, and neither of you can fight them back any longer.

A Moment of Stillness ❤️🧸🔔 F!reader / 2.6k / Worrying and caring about his brothers all the time weighs heavy on Hunter. So, it’s a good job you’re there to worry and care about him.

Waiting for You ❤️🫦🔔 F!reader / 6.8k / A night out at 79’s leads to a revelation that surprises the whole batch, and with feelings becoming increasingly more difficult to hide, it was only a matter of time before you and Hunter reached a crossroads. (Pre Echo)

Whispers of Home's Embrace ❤️🧸🔔 F!reader / 2.1k / Hunter has always been calm and strategic, but with Omega's prolonged absence, he's unraveling at the seams, working himself into the ground. It's a good thing you're there to slow him down, and remind him that neglecting himself in the process isn't healthy.

A Place Called Home ❤️🧸🔔 F!reader / 3.2k / Determined to leave the fighting and running behind now that your little family are all together again, you settle into your new home in Upper Pabu.

Echo

Kibo and Kisses 🧸❤️ F!reader / 3.3k / Taking a breather on a remote plan after working yet another job for Cid, Echo steals away with you for a moment.

Chasing Away the Nightmares 😢🧸🔔 F!reader / 2k / Although Echo is integrating into life with the Bad Batch, and is getting used to his new body, sometimes the nightmares come back to haunt him. Thankfully, you’re there to help him through them.

Crosshair

Such a Good Girl ❤️🫦 F!reader / 4.2k / Crosshair can’t shake this strange feeling in his chest, especially after you save his ass during a mission. Perhaps it's worth finally exploring.

Catch the Sunrise 😢 F!reader / 1.9k / As Crosshair struggles to integrate into life on Pabu after being rescued from Mount Tantiss, you try to reconnect with him and draw him out of his shell.

Equilibrium 🧸❤️🔔 F!reader / 1.5k / When your body betrays you, there’s no one else in the galaxy you’d rather have at your side.

Cracks in the Wall 🧸❤️🔔 F!reader / 2.8k / Not much could ruffle Crosshair's feathers or get past the wall he'd built around himself over the years - until he met you.

To Be Cared For 😢🧸🔔 F!reader / 1.9k/ After successfully rescuing Crosshair, Tech, and Omega from Mount Tantiss, you settle down with the Batch on Pabu to live out the rest of your lives. But it’s not an easy transition for the sharpshooter after everything he’s been through.

In the Light of Day 🧸❤️ F!reader / 1.6k / After years of buried feelings, you and Crosshair wake beside each other, the line between friendship and romance blurred. In the light of day, you both confront the uncertainty of what lies ahead.

Never Stopped 😢🧸❤️🔔 F!reader / 2k / When Omega's cryptic message leads to a heartfelt reunion on Ryloth's nearest moon, you didn't expect her to be accompanied by the one man you never thought you'd get to see again.

Through Your Eyes 🧸❤️🔔 F!reader / 3k / In a galaxy consumed by war, you find solace away from the medbay and injured troopers by painting your dreams. But a chance encounter reveals those dreams are more than they seem...

Gentle Hands 🧸❤️ F!reader / 1.4k / Back on Kamino after successfully rescuing Echo and retaking Anaxes, you know just how to soothe Wrecker’s lingering back pain.

What’s Mine is Yours ❤️🫦🔔 F!reader / 4.2k / While working on a mission on Corellia, a clothing mishap leads to much more than you anticipated.

Group

Painted Pretty ❤️🫦 F!reader / 3k / Travelling through hyperspace after a mission can be boring, unless you’re sharing a ship with five men.

Unravelling the Pact ❤️🫦 F!reader / 3.6k /  After back-to-back missions, you and the boys finally get some downtime. Enjoying the nightlife on Coruscant, a stranger is all too willing to dance with you, leading to the boys making a decision that will change everything. Pre-Echo.

As One Door Closes 🧸🔔 F!reader / 2.3k / As the Empire’s grasp on the galaxy deepens, you have no choice but to move your parents to the safety of Pabu. While having them close once again is a blessing, it means closing the door on your childhood home one last time.

Brotherly Bonds  😢🧸🔔 Cadet Batch / 2.5k / The holonet can be a wonderful yet vicious place. When Wrecker’s feelings are hurt, and he questions his place in the squad, his brothers rally together to fix it and comfort him.

Wash Away the Pain 😢 Echo / Hunter / Tech / Wrecker / Crosshair War and its aftermath are never easy. But sometimes, a shower and a kind word can make a small difference.

Take a Breath 🧸🔔 gn!reader / 1.5k / Most of the time you can keep up with your boys, but sometimes those old breathing problems come back to bite you. Thankfully, you no longer need to deal with them on your own.

Wolffe

Part of the Pack 🧸❤️🔔 F!reader / 2k / Amidst the chaos of the war, you've found solace and love in the arms of your grouchy Commander. As you steal a moment away from the battlefield, the future becomes all that more exciting.

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