Clinical Research Associate

ExThera Medical

Bandar Baru Enstek, Negeri Sembilan

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.

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

Monitoring and Site Management :
• Perform site... More Detail

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