Covance Clinical Trial Coordinator 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
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
Job Number 2018-23039
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.