About the job
Join Precision for Medicine as an In-house Clinical Research Associate I/II and contribute to advancing clinical research initiatives from the comfort of your home in France!
Position Overview:
The In-house CRA I/II plays a vital role in supporting both clinical project teams and study sites involved in clinical research. This position requires adherence to established protocols, standard operating procedures (SOPs), and relevant regulatory guidelines, including International Council for Harmonization (ICH) Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country-specific regulations. The In-house CRA acts as a primary communication link for study sites and demonstrates solid teamwork by executing core responsibilities effectively across multiple studies using independent judgment and critical thinking.
Key Responsibilities:
- Support investigator recruitment through phone scripts, questionnaires, and study site materials.
- Assist in site feasibility and recruitment tasks, including managing recruitment questionnaire responses.
- Coordinate internal and external meeting schedules as necessary.
- Prepare and distribute Investigator Site Files to study sites, coordinating with shipping vendors when needed.
- Collect, review, and maintain essential documents, ensuring compliance with ICH/GCP guidelines and local regulations throughout the trial master file (TMF).
- Set up and maintain site-related data in relevant clinical systems, using Clinical Trial Management Systems (CTMS) to track milestones and activities accurately.
- Act as a liaison for study and site management issues, addressing inquiries and assisting with study supplies management.
- Ensure timely and complete data entry by study sites in Electronic Data Capture (EDC) systems.
- Disseminate updates, newsletters, and essential study documents to study site personnel.
- Provide logistical support for sample management and tracking.