Clinical Research Associate - Germany

Meditrial; Erfurt; On-site; EUR 70,000 - 110,000; Full time

Job summary

Meditrial in Germany seeks a certified Clinical Research Associate with extensive medical device trial experience to join our team. The CRA will monitor Phase I–IV trials, conduct site evaluations, initiations, interim and close-out visits, and collaborate with Clinical Project Managers and CTAs.

The ideal candidate has a proven track record in medical device trials, particularly in cardiology, is fluent in English and German, and is willing to travel for site visits and monitoring activities as

Qualifications

• Minimum 6+ years of experience in clinical trial monitoring for CROs and sponsors.
• Expertise in medical device trials, especially cardiology.
• CRA certification with a proven track record.

Responsibilities

• Conduct on-site and remote monitoring visits from SIV to Close-Out Visit.
• Train investigators and site personnel on study protocols.
• 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

Clinical trial monitoring

eCRF

CTMS

English and German fluency

Travel willingness

Education

Specialized degree in natural sciences

CRA Certification

Tools

eCRF

CTMS systems

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.