Industry: Medtech, Digital Health
Job Functions: Site Monitoring for clinical trials with medical device
Location: Canada
Workplace: remote/availability to travel
Meditrial is seeking a certified Clinical Research Associate (CRA) with extensive experience in medical device clinical trials to join our dynamic team. The CRA will be responsible for monitoring Phase I-IV clinical trials, ensuring compliance with Good Clinical Practices (GCP) and study protocols. This role involves conducting site evaluations, initiation, interim, and close-out visits, as well as collaborating closely with Clinical Project Managers and CTAs.
The ideal candidate will have a proven track record in medical device trials, particularly in cardiology, and must be available to travel for monitoring activities as needed.
Responsibilities
Conduct on-site and remote monitoring visits from SIV (Site Initiation Visit) to COV (Close-Out Visit), ensuring study sites adhere to protocols and regulatory requirements.
Train investigators and site personnel on study protocols and best practices.
Review Case Report Forms (CRFs) and verify entries against source documentation.
Document site visits, findings, and follow-ups in detailed reports.
Facilitate communication among investigative sites, sponsors, and internal teams.
Identify and assess potential investigators in collaboration with sponsors.
Ensure compliance with FDA, ICH-GCP, and local regulatory guidelines.
Assist in study submissions and preparation of regulatory documents.
Support project teams with study communications and trial management activities.
Qualifications
6+ years of experience in clinical trial monitoring for CROs and Sponsors, with a strong focus on medical device trials.
Expertise in cardiology trials and experience across other therapeutic areas.
Higher or specialized degree in natural sciences (e.g., Biology, Medicine, Pharmacy, or related fields).
CRA Certification with a track record of successful monitoring visits.
Proficiency in electronic CRF (eCRF), CTMS systems, and other digital tools.
Background in CROs, pharmaceuticals, biotechnology, and medical devices.
Fluency in English (a second language is a plus).
Willingness to travel as required for site visits and monitoring activities.
Fluency in English and French
