Clinical Research Associate monitoring Canadian clinical trials for Parexel, a global clinical research organization. Managing site relationships, compliance, data quality, and study delivery.
About the role
- Senior Clinical Research Associate conducting onsite monitoring and regulatory support for a global medical research company in Canada. Managing clinical-trial sites, CRFs, queries, audits, and study submissions.
Responsibilities
- Conduct and report SIV, RMV, and COV onsite monitoring visits
- Perform CRF review, source document verification, and query resolution
- Manage site communication and management
- Serve as a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support the regulatory team in preparing documents for study submissions
- Prepare for and participate in audits and inspections
Requirements
- College/University degree in Life Sciences or equivalent combination of education, training, and experience
- Independent on-site monitoring experience
- Experience with all types of monitoring visits in Phase II and/or III
- Experience in Oncology is a plus
- Full working proficiency in English and French
- 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
- Must not require work visa sponsorship for employment now or in the future
Benefits
- Remote work option
- Opportunity to further develop skills
- Opportunity to widen therapeutic area experience
- Opportunity to become an expert in clinical research
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