Premier Research is looking for a Clinical Research Associate II/Senior CRA - French Fluency to join our Clinical Monitoring, Site Management and SSU 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
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:
- Perform monitoring activities (both on site and remote) including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Site Management Contacts, Close Out Visits for Phase I-IV clinical trials, as well as device trials with opportunities to work in the following Therapeutic areas: oncology, pediatrics, rare disease.
- 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.
- 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, along with minimum of 4+ years previous on-site clinical research monitoring experience required.
- Must have French fluency and be based in Quebec
- 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
- Experience with monitoring oncology/neurology/rare disease/dermatology studies are preferred
- Accountable, dependable and strong commitment
- Ability to meet the requirement of 8-10 DOS (Days on site)/monitoring visits/month; 70-85% travel
- Valid driver’s license, passport as required
