Clinical Research Associate II

Premier Research; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

Premier Research is seeking a Clinical Research Associate II to join their Global Clinical Monitoring team. This role involves monitoring clinical studies, ensuring data integrity, and preparing monitoring reports. Candidates should possess an undergraduate degree in a relevant field and a minimum of 2 years of clinical trials experience. Join the team and contribute to innovative medical developments that can change lives.

Qualifications

• Completion of CRA training program required.
• At least 2+ years' experience in clinical trials, including independent monitoring.
• Experience in Phase I and Medical Device studies is an advantage.

Responsibilities

• Delivering quality, timely monitoring reports for sponsor approval.
• Planning day-to-day activities for monitoring of clinical studies.
• Maintaining Trial Master File and ensuring site documents are accurate.

Skills

Clinical research experience

Data integrity

Patient safety

Monitoring

Education

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

Licensed health-care professional

Job description

Premier Research is looking for a Clinical Research Associate II 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 2+ years' experience in clinical trials to include independent monitoring
• Experience in Phase I and Medical Device studies an advantage.