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:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.
- Monitoring activities will be across Belgium, Netherlands and possibly France.
- 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.
- May be responsible for multiple studies and must work independently with team support.
You'll need this to be considered:
- 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
- Experience in monitoring complex trials or global trials or equivalent experience
- Ideally experience in working in the following therapeutic areas: Oncology, Pediatrics, Rare Disease, Neurology and / or Medical Devices.
- Preference for multiple languages i.e. Dutch and French, however, at a minimum, candidates must have fluency in Dutch.
- This is a contract position and is offered as a 0.5 FTE with a contract duration of 6 months.