Senior Clinical Research Associate

Premier Research Group; United Kingdom; Remote; GBP 45,000 - 65,000; Full time

Job summary

A leading company in clinical research seeks a Senior Clinical Research Associate to join their Global Clinical Monitoring and Site Management team in the UK. The position involves monitoring clinical trials, ensuring data integrity and patient safety, and requires significant clinical research experience. The role is remote and allows for work-life balance while contributing to crucial medical innovations.

Qualifications

• 4+ years of experience in clinical trials including independent monitoring.
• Experience in Phase I and Medical Device studies is a plus.
• Completion of CRA training program required.

Responsibilities

• Deliver monitoring reports for sponsor approval per timelines.
• Conduct on-site qualification and monitoring visits.
• Maintain the Trial Master File (TMF) as per guidelines.

Skills

Clinical research experience

Data integrity

Patient safety

Monitoring reports

Education

Undergraduate degree in clinical, science, or health-related field

Licensed health-care professional

Job description

Senior Clinical Research Associate page is loaded

Senior Clinical Research Associate

Apply remote type Remote locations United Kingdom time type Full time posted on Posted Yesterday job requisition id R5326 Premier Research is looking for a Senior Clinical Research Associate to join our Global Clinical Monitoring and Site Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• We are Built by You. Your ideas influence the way we work, and your voice matters here.

• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
  

Together, we are Built for Biotech. Join us and build your future here.

What You'll be Doing:

• Delivering quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintaining submission of expenses according to travel and expense requirements within company guidelines
• Countrywide monitoring (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Planning day to day activities for monitoring of a clinical study and setting priorities per site
• Preparing for and conducting on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates

What we are searching for:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Previous clinical research experience required, completion of CRA training program
• At least 4+ years in clinical trials to include independent monitoring.
• Experience in Phase I and Medical Device studies an advantage.

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