Are you an experienced Clinical Research Associate (CRA) with a passion for driving innovative medical advancements?
Do you want to play a key role in bringing life-saving treatments to patients?
Join our client’s team and contribute to cutting-edge clinical research in the medical device field!
Key Responsibilities:
Oversee clinical project management and day-to-day operations across all study phases, from start-up to close-out.
Develop, write, and maintain essential clinical study documentation.
Support the submission of study-specific documents to regulatory authorities, including ethics committees and competent authorities.
Ensure compliance with clinical study protocols, ISO-14155, ICH-GCP, MDR, and other relevant regulations.
Maintain and manage Trial Master File (TMF), tracking essential study documents accurately.
Serve as the primary liaison for study sites, ensuring timely resolution of queries and protocol adherence.
Support clinical data collection, review, and cleaning activities to ensure high data quality.
Conduct co-monitoring and monitoring visits, along with sponsor-initiated site visits.
Coordinate meetings, teleconferences, and study-related updates with Clinical Affairs leadership.
Collaborate cross-functionally to ensure the smooth execution of clinical studies.
Requirements:
Bachelor’s degree in Life Sciences, Nursing, or a related field.
2+ years of experience as a CRA or CPM in the medical device industry or a Contract Research Organization (CRO).
Strong knowledge of ISO-14155, ICH-GCP, MDR, and regulatory guidelines.
Experience with electronic data capture and tracking systems.
Monitoring experience is a plus.
Excellent organizational, teamwork, and communication skills.
Proficiency in Microsoft Office.
Fluency in English is required; German language skills are a plus.
What’s in it for you?
A unique opportunity to join a growing, innovative medical device company.
A dynamic role where you’ll work closely with clinical management and make a real impact.
Career growth in a collaborative, fast-paced environment dedicated to improving patient care.
If you're ready to take the next step in your career and contribute to life-changing medical advancements, apply now and/or contact Hollie Dear at Adaptive Life Science for more information!
