Lead on-site monitoring activities for Phase II/III studies in Canada, including SIV/RMV/COV visits, CRF review, source data verification, query resolution, site management, regulatory submission support, feasibility, and audit/inspection preparation. Act as site and vendor contact and communicate study progress with internal teams.
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global, mid-size company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
We are looking for an experienced freelance Sr. CRA to support us with the following responsibilities in Canada:
- Conduct and report SIV, RMV, COV onsite monitoring visits
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Prepare and particiapte on audits and inspections
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in Oncology is a plus
- Full working proficiency in English and French is essential.
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
- Valid driver’s license
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
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