Senior Clinical Research Associate
RemoteMontréal, Quebec, Canada
Montréal, Quebec, CanadaRemoteFull TimeSenior LevelBachelors DegreeEnterprise
Full TimeSenior LevelBachelors DegreeEnterprise
Job Summary
Senior Clinical Research Associate with Oncology experience to monitor and manage sites in Montreal/Quebec. Responsibilities include site qualification, initiation, monitoring, and closure of study sites in compliance with ICH-GCP and local regulations; training and support for investigators and site staff; updating CTMS and ensuring timely reporting, data management, and QA through risk-based monitoring; collaboration with Local Study Team and MSLs; and ensuring sites remain inspection-ready through audits and regulatory inspections.
Required Qualifications
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Good knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant client’s Therapeutic Areas
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management
- Excellent attention to details
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation skills
- Ability to travel nationally/internationally as required
- Valid driving license
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