Clinical Research Associate - Germany
Company: Meditrial
- Location: Erfurt, Germany
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
Industry: Medtech, Digital Health
Job Functions: Site Monitoring for clinical trials with medical device
Location: Germany
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 and Germany
- Willingness to travel as required for site visits and monitoring activities.
