Clinical Project Specialist - 1 Yr Contract

Responsible for the effective management and implementation of clinical trials in the Clinical Research Unit (CRU) in compliance with all relevant Standard Operating Procedures (SOPs), Good Clinical Practice Guidelines (GCP) and relevant regulatory requirements.

Serves as the primary liaison between CRU study team and Sponsor on operational matters, Sponsor representatives (e.g. monitors, vendors) and Ethics/Institutional Review Board (ERB).

• Manages study implementation from planning to closeout.
• Liaises with the sponsor and site study team during the development phase of the protocol to ensure consistency and operational viability of a protocol.
• Provides leadership in the review and development of study-related documents such as protocol, informed consent document, case report forms, source document worksheets, and CRU tools for study compliance (e.g. activity schedul...