Senior Clinical Research Associate
EPM Scientific are currently partnered with a growing Contract Research Organisation specialising in medical device clinical research. They are urgently seeking a Senior Clinical Research Associate (Sr. CRA), reporting to a Clinical Operations Manager, to support the successful delivery of innovative medical device clinical studies across Germany and wider Europe. This position will play a key role in ensuring clinical investigations are conducted in compliance with applicable regulations, GCP standards, and study requirements whilst supporting sites throughout the full trial lifecycle. See a summary of the role below:
Role Overview:
- Start date: ASAP
- Location: Germany, Remote
- Contract Type: Freelance / Consultant - 1 FTE, 12 Months Contract
- Language: German and English
- Project: Innovative Medical Device Clinical Studies
Key Responsibilities:
- Perform site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols, GCP, and SOPs.
- Ensure clinical investigations are conducted in compliance with ISO 14155, EU MDR, applicable regulations, and study requirements.
- Build and maintain strong working relationships with investigators, site personnel, and cross-functional study teams.
- Monitor patient safety, data quality, protocol compliance, and timely resolution of study issues and deviations.
- Support investigative product accountability, site documentation management, and essential study records.
- Identify, communicate, and proactively manage study risks, enrollment challenges, and operational issues throughout the trial lifecycle.
- Contribute to regulatory and ethics committee submissions, study documentation reviews, and clinical reporting activities.
- Mentor junior CRAs where required and support continuous improvement initiatives within Clinical Operations.
Requirements:
- Bachelor's degree in a Life Sciences, Nursing, Biomedical, or related scientific discipline.
- Minimum 5 years of CRA experience, including hands-on monitoring of medical device or clinical research studies.
- Strong knowledge of ICH-GCP, ISO 14155, and European clinical research regulations; familiarity with EU MDR is highly desirable.
- Demonstrated experience conducting independent monitoring visits and managing investigator sites throughout the study lifecycle.
- Experience working with EDC systems, eTMF platforms, and standard clinical trial documentation.
- Excellent communication, stakeholder management, and organisational skills with the ability to work autonomously.
- Fluent German and English language skills are required.
- Willingness to travel approximately 25-50% across Germany and Europe.
If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.
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