Senior Clinical Research Associate

Senior Clinical Research Associate

Premier Research

Remote, Romania

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

What you'll be doing:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintains submission of expenses according to travel and expense requirements within company guidelines
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plans day to day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintains 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’ experience in clinical trials

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