Job Description

Job Summary:

We are seeking a highly motivated and experienced contract part-time CRA with a strong background in medical device clinical trials. The ideal candidate will support project setup, site initiation, and administrative processes. A medical or nursing education is preferred, along with hands-on experience in regulatory submissions, budget negotiations, and site management in the medical device industry.

Job Responsibilities:

  1. Ensure clinical trials are conducted in compliance with ISO 14155, ICH-GCP, local regulations, and company SOPs.

  2. Verify data integrity and ensure the rights, safety, and well-being of trial participants are protected.

  3. Conduct study start-up activities, including site initiation and document collection.

  4. Independently perform routine monitoring visits, including site monitoring and close-out visits.

  5. Manage study supplies and ensure appropriate inventory at cl...

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