Trial Master File Specialist
- The Trial Master File Specialist is responsible for the appropriate scan, index, quality check, file, archival and retrieval of records for the Clinical Operations’ section of the Trial Master Files (TMF). This individual will provide expertise in record management and archival support for Clinical Operations including but not limited to the safekeeping and accessibility of Clinical Operations’ Trail Master File records for all client sponsored clinical studies by ensuring records are appropriately and securely filed and archived. This position is responsible to support the definition, implementation, execution and process improvement of storage activities for both active and inactive studies.
- Demonstrated archiving experience.
- Solid knowledge of clinical operations, clinical studies, and GCP
- Demonstrated professional experience using Trial Master File (TMF)
- Minimum of a High School Diploma or GED
- Skilled in Microsoft Excel, SharePoint and Word
- Bachelor's Degree Preferred
- Excellent interpersonal skills
- Ability to multi-task, be flexible, and thrive in a fast-paced team environment
- Ability to handle a high volume of complex tasks within a given timeline
- Ability to work in a team environment as well as independently
PLEASE NOTE: 3RD PARTIES/SUBCONTRACTORS/SUBCONTRACT AGENCIES ARE NOT ELIGIBLE FOR THIS POSITION. SUBCONTRACT AGENCIES NEED NOT APPLY.