Note: The job is a remote job and is open to candidates in USA. Meditrial is a medtech and digital health company. The Senior Clinical Research Associate will monitor Phase I-IV medical device clinical trials, ensuring compliance with Good Clinical Practices and study protocols while conducting site visits, training investigators, reviewing clinical data, and supporting regulatory and trial management activities.
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
Skills
- 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
- Willingness to travel as required for site visits and monitoring activities
- Fluency in English (a second language is a plus)
Benefits
- Remote workplace arrangement
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