Position is located in Montreal, Canada
Get ready to redefine what's possible and discover your extraordinary potential at Covance. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients—and your career.
We have job openings for Clinical Trial Coordinators to be office based in Montreal, Canada!
*Must be bi-lingual in French and English.
The Clinical Trial Coordinator will support tasks associated with study start-up.
Responsibilities associated with this position:
- Develop project specific plans for the GSS component of assigned studies
- Liaise with operational project team regarding project issues (i.e., participate in team meetings)
- Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
- Review and approve patient informed consents for compliance per protocol
- Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent)
- Prepare new investigator submission packages to Local and Central IRB / IEC
- Provide milestone information for incorporation into weekly analysis sheets
- Monitor performance of GSS team with regard to project timelines
- Manage the drug supply vendor activities as applicable
- Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes
- Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place
- Create surveys to probe “thought leaders,” experienced researchers, and clinicians in the field
- Conduct follow-up calls with Investigators and/or Study Coordinators to solicit in-depth information related to feasibility, and obtain further detailed information regarding potential proposals
- Conduct QC of feasibility documents as required by the process
- Directly manage day to day conduct with clients for stand-alone feasibility activities and other feasibility activities as appropriate
Covance believes that their best-in-class employees deserve first-class benefits. Covance offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short and long-term disability, and life insurance.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
- University/College degree (life science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
- 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered
- Must be bilingual in French and English
- Ability to drive and possess a valid driver's license
- Ability and willingness to present at internal and external meetings
- Less than 10% travel may be required both international and domestic
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