Job Title

Senior Clinical Research Associate (M/F/X) Key Responsibilities Oversaw and coordinated all study start-up activities in Canada, ensuring study documentation (including informed consent materials) was adapted to meet national regulatory standards and Ethics Committee requirements Led the preparation and coordination of regulatory and ethics submissions, managing approval processes with Health Canada and relevant ECs Negotiated site agreements and managed contractual discussions, serving as the central liaison between study sites and the project team Guided investigational sites through the start-up phase, supporting readiness activities and ensuring Site Initiation Visits were executed efficiently and on schedule Following budget confirmation after site initiation, assumed responsibility for clinical monitoring, performing a combination of on-site monitoring visits (based on enrolment levels) and regular remote monitoring activities Maintained continuous communication with Data Management and cross-functional teams, delivering timely reports and escalating risks or issues in a transparent and structured manner Ensured ongoing completeness, accuracy, and inspection readiness of site documentation, including the Investigator Site File and Site Master File, throughout start-up and study conduct Administered site progress and timelines within Veeva CTMS, maintaining accurate tracking of milestones and start-up deliverables Supported site payment processes by validating required documentation and proactively following up to ensure timely invoice submission Independently addressed operational, regulatory, and site-related challenges, frequently extending beyond standard CRA or project management responsibilities to support cross-functional needs Actively collaborated with internal teams to identify practical solutions, contributing to overall project efficiency and team performance Requirements Minimum 5+ years of experience as a Senior CRA or PM in RWD/epidemiological studies Fluent in English; French proficiency preferred Willingness to travel domestically for SIVs, monitoring visits, and meetings as needed Proficiency in Veeva CTMS and Microsoft Office suite; experience with GEP guidelines Excellent organizational skills, with the ability to manage multiple priorities in a fast-paced, remote-hybrid environment Strong negotiation and communication skills for stakeholder engagement