Senior Centralized Study Associate
hace 5 días
You will join an international team dedicated to support all types of clinical trials at the start up as during the course of the study.
Main tasks consist of document review:
- Review Initial Greenlight Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial
- Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
- File Informed Consent Form and Investigator Package approval documentation in TMF
- Review Start-up Plans that document the required quality of documents, client interactions etc for the ICF & Greenlight Packages following the available SOP with manager oversight
- Review of Patient recruiting material
Other study support can be
- US IRB submission
- Country ICF customization
- Essential document creation
- CTMS compliance management
**Labcorp is proud to be an Equal Opportunity Employer**:
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