Clinical Project Coordinator - NCR
Novella Clinical Resourcing is seeking a Clinical Project Coordinator for a permanent opportunity in the San Francisco area.
1) Drug Management and Supply Process
- Acts as a liaison between investigational product distributors and study sites.
- Facilitate the ordering of investigational product between sites and distributors, alerting distributors to any temperature excursions or complaints, and communicating instructions to sites regarding them.
- Create new ordering forms as needed
- Update Drug Management Plan for each new investigational product
- Support drug labeling process for study by product distributor
- Review and collate receipt of forms prior to submitting to product distributors
- Update Manual of Operations and Procedures, as required
2) Management of Trial Master File (TMF)
- Audit TMF received by prior CRO and collating and organizing files
- Assist in investigate feasibility of transferring to an electronic TMF system
- Responsible for transferring files to new electronic system
- Participate in the development of SOPs regarding process for storing documents
- Maintain the TMF
3) Generate data reports
- Tracking and reporting on various study metrics, and responding to data queries.
- Create monthly reports including: site accrual, screen failure rates, pCR data status, and the completeness of all other case report forms by site
- Create ad hoc reports: created in response to data queries, or to specific events in the trial (such as an arm closing).
- BA, BS, AA or AS degree in life sciences, nursing or related disciplines
- Basic or Clinical research or healthcare-related experience is desired (0-2 years)
- Experience in MS Office products (e.g. Excel, Power Point & Word)
EEO Minorities/Females/Protected Veterans/Disabled
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