Senior Clinical Research Associate

Premier Research; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company in clinical research is seeking a Senior Clinical Research Associate to support biotech and pharma firms in bringing innovative medicines and devices to market. This vital role demands a mix of extensive clinical trial experience, a strong educational background, and a commitment to patient safety and data integrity. As part of a team that values your input, you will be pivotal in delivering impactful medical solutions.

Qualifications

• 4+ years in clinical trials with independent monitoring.
• Experience in Phase I and Medical Device studies advantageous.

Responsibilities

• Delivering quality, timely monitoring reports.
• Conducting on-site qualification and monitoring visits.
• Maintaining Trial Master File and ensuring data accuracy.

Skills

Quality Monitoring

Data Integrity

Patient Safety

Education

Undergraduate degree in clinical, science or health-related field

Completion of CRA training program

Job description

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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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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