Responsibilities include but, are not limited to:
Supports clinics logistics as described for previous grade. Participates on cross-functional project teams and may be assigned program management.
Serves as primary liaison and clinical trial resource for the screening and enrollment of clinical trial participants across multiple clinical studies.
Serves as back up liaison and clinical trial resource for the screening and enrollment of clinical studies.
Proactively communicates with site research staff, vendors, and manufacturing to schedule and coordinate the “cell journey” activities as well as initiation/completion of study treatment and subsequent patient visits.
Coordinates all aspects of study participant sample collection and “cell journey” including apheresis, shipping, processing, manufacturing and return of investigational product back to the clinical trial sites.
Communicates study requirements while ensuring adherence to the cell journey process.
Assists in the refinement and improvement of the cell journey process including the screening/enrollment of trial patients, patient scheduling and treatment process.
Prepares metrics and updates for management as assigned. Proactively identifies potential study issues/risks and recommends/implements solutions.
Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met.
Leads internal team meetings and provides training as necessary at investigator meetings and other trial-specific meetings.
Participates in the development, review and implementation of departmental SOPs and processes.
Creates and manages clinical logistics programs as assigned.
Supports cross functional projects.
Travels as required.
Other duties as assigned.