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).

Position Requirements

  • 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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