Description

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