Job Overview
- Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study.
- Verifies that the rights and well-being of human subjects, clinical study’s participants, are protected and conducts monitoring to confirm subject safety and data integrity.
- Acts as the main point of communication with Investigator and site team; documents conducted communication as per the study specific guidelines.
- Trains investigational site staff as necessary.
- Participates in feasibility studies for new projects, as required.
- Supports preparation of regulatory and / or EC submissions
- Supports site contracting in the specific country.
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