Our client is currently seeking a Lead CRA / Jr Project Manager for a 12 month contract role to be based at either their North West London or Cambridge site.
The Lead CRA / Jr Project Manager will contribute to the preparation and/or review of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets.
PRINCIPAL RESPONSIBILITIES include:
Identify clinical trial investigators
Coordinate preparation and conduct of monitors workshops and investigator meetings
Coordinate study-level investigational product arrangements, accountability and reconciliation
Coordinate activities associated with site start-up and management including review of site-modified informed consent forms and tracking of the budget and contract process
Provide extensive clinical site/CRA support by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations)
Coordinate shipment and analysis of clinical biological samples
Monitor progress of studies, identify study-related trends/issues and work to implement corrective actions when necessary
Provide input to clinical study timelines and budgets
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Clinical research experience obtained working on clicial trials at a biotech, pharmaceutical or CRO company
Experience with outside vendors
Experience with administration of site budges and grants
Fforde is acting as a recruitment agency/business.
KEY WORDS: Lead CRA , Principal CRA, Associate study manager, Clinical Trials, Drug Development, Clinical Development, Clinical Research, Clinical Monitoring, matrix management, start up, close out, feasibility, project management, CRO, Pharmaceutical, ICH/GCP, Contract, England