Clinical Research Associate - German Speaking
Remote
Contracted
Experienced
The Role
ExThera Medical is seeking a freelance Clinical Research Associate (CRA) with proficiency in German and expertise in study start-up and close-out activities. The ideal candidate will be responsible for supporting clinical trials conducted in German-speaking regions, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. PLEASE DO NOT APPLY IF YOU ARE NOT FLUENT IN GERMAN ~ THANK YOU
Study Start-Up Activities:
What you Bring
This is a freelance position offering flexibility in work hours and location (preferred location in Germany but will consider anywhere in Europe or the United States).
ExThera Medical is seeking a freelance Clinical Research Associate (CRA) with proficiency in German and expertise in study start-up and close-out activities. The ideal candidate will be responsible for supporting clinical trials conducted in German-speaking regions, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
PLEASE DO NOT APPLY IF YOU ARE NOT FLUENT IN GERMAN ~ THANK YOU
A Few Key Responsibilities
Study Start-Up Activities:- Assist with the preparation and submission of regulatory documents for study approval.
- Coordinate site selection, initiation visits, and investigator meetings.
- Conduct site feasibility assessments and ensure sites are appropriately qualified for participation.
- Collaborate with investigators and study teams to develop study-specific documents, such as protocols, informed consent forms, and study manuals.
- Provide training and support to site staff on protocol requirements and study procedures.
- Perform site initiation, routine monitoring, and close-out visits according to study protocols and monitoring plans.
- Ensure adherence to protocol, GCP, and regulatory requirements during site visits.
- Monitor study progress, data collection, and patient safety, identifying and resolving issues as needed.
- Maintain accurate and timely documentation of site activities and monitoring visits.
- Coordinate study close-out activities, including site close-out visits and documentation review.
- Verify completion of study procedures, data collection, and investigational product accountability.
- Ensure proper archiving of study documents and regulatory files in compliance with regulatory requirements.
- Assist in the preparation of study reports and contribute to final study documentation.
What you Bring
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 5 years of experience as a Clinical Research Associate, preferably in a freelance capacity.
- Fluent in German (written and spoken) with proficient communication skills in English.
- Proven experience in study start-up and close-out activities, including regulatory submissions, site selection, and site management.
- Strong understanding of GCP guidelines, ICH regulations, and regulatory requirements for clinical trials.
- Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
- Proficiency in Microsoft Office applications and clinical trial management systems.
This is a freelance position offering flexibility in work hours and location (preferred location in Germany but will consider anywhere in Europe or the United States).
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