Description
Primary responsibilities include:- Conducts and/or oversees all activities required for selecting, initiating, monitoring and closing investigational sites
- Serves as a primary contact for internal study team members and external vendors
- Provides oversight of CRO interactions in the areas of study/project management, monitoring, site management, trial master files, and data management
- Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
- Provides timely and accurate information to Project Management for program level tracking
- Participates in evaluating study drug supply requirements and manages the logistical aspects of distributing supplies to the investigational sites
- Coordinates investigator meetings and develops presentation materials
- Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies
- Identifies program/clinical trial risks; proactively suggests and implements mitigation strategies
- Participates in the evaluation, selection and eventual management of vendors
- Participates in the preparation and finalization of company SOPs
Skills / Education / Requirements:
Candidates must have a BA or BS desgree with a minimum of five years related clinical operations experience (4 years minimum as a CRA and in a lead role). A strong medical/science background with oncology experience is highly desirable. Prior global trial experience required. Knowledge of GCP/FDA/ICH regulations required.
Candidates MUST live in the San Francisco / Bay Area region.