Premier Research is looking for a Clinical Research Associate II to join our 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.
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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.
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Your ideas influence the way we work, and your voice matters here.
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As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
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 independent monitoring
This is a contract position which is being offered as a 0.5 FTE with a duration of 1 year. Candidates should be either immediately available, or available to start at short notice and should be seasoned contractors / freelancers.