Senior Clinical Research Associate

EPM Scientific; Deutschland; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

EPM Scientific is seeking a Senior Clinical Research Associate to support medical device clinical studies across Germany and wider Europe. You will conduct site visits, monitor trials, and ensure compliance with GCP, ISO 14155, and EU MDR while coordinating with investigators and cross-functional teams.

Fluent German and English are required; travel is approximately 25–50% across Germany and Europe as part of the role.

Qualifikationen

• 5+ years of CRA experience, including monitoring medical device or clinical studies.
• Strong knowledge of ICH-GCP, ISO 14155 and EU MDR familiarity.
• Experience with independent monitoring visits and site lifecycle management.

Aufgaben

• Perform site selection, initiation, routine monitoring and close-out visits per protocol.
• Ensure investigations comply with ISO 14155, EU MDR and applicable regulations.
• Build relationships with investigators and site staff across Europe.
• Monitor patient safety, data quality and protocol deviations; resolve issues.
• Support product accountability, site docs, and essential study records.
• Identify risks and manage enrollment and operational challenges throughout trials.
• Contribute to regulatory submissions, study documentation, and reporting.
• Mentor junior CRAs and support continuous improvement in Clinical Ops.

Kenntnisse

Site monitoring

Regulatory compliance

Stakeholder management

Autonomous work

German & English fluency

Ausbildung

Bachelor's degree in Life Sciences or related field

Tools

EDC systems

eTMF platforms

GCP standards

ISO 14155

Jobbeschreibung

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:

• Location: Germany, Remote
  
• Contract Type: Full-time, Permanent
• 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.