Senior Clinical Research Associate conducting onsite monitoring and regulatory activities for a global medical research company. Supporting Phase II/III studies and Canadian clinical-trial sites.
Responsibilities
Conduct and report SIV, RMV, and COV onsite monitoring visits
Perform CRF review, source document verification, and query resolution
Manage site communication and site relationships
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 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
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 available
Opportunity to further develop skills
Opportunity to widen therapeutic area experience
Opportunity to become an expert in clinical research
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