Premier Research is looking for a 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:
- Perform monitoring activities (both on site and remote) with a focus on data integrity and patient safety in accordance with specific country regulations for Phase I-IV clinical trials, as well as device trials with opportunities to work in the following Therapeutic areas: neurology, psychiatry, cardiovascular, dermatology, oncology, pediatrics, rare disease, diagnostics or women’s health.
- Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
- Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators’ Meetings, and complete other project tasks in accordance with study timelines and budget.
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- Identify and escalate potential risks and possible retraining opportunities for investigative sites.
- Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high quality trip reports, and active management of all deliverables.
What we are searching for:
- Undergraduate degree required or its international equivalent, with preference for Nursing or Medical degrees
- Previous clinical research experience desired, with priority for 3-5 years experience as site level coordinator
- Preference for sponsor-initiated clinical trial experience in Neuroscience, Dermatology, Cardiovascular, or Oncology studies
- Ability to meet the requirement of 8 DOS (Days on site)/monitoring visits/month.
- You must live in Quebec, Canada and be fluent in French.
- Must have valid driver's license, passport as required
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas
- Accountable, dependable and strong commitment
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