Will be expected to: coordinate and lead project team meetings and update the Clinical
Development Team on timelines and milestones for the study; review and negotiate contracts;
contribute to the development of study documentation including protocol review, and creating
study manuals, and CRFs; participate in study site selection; review and update site specific
consent forms; track patient accrual and study progress via standard reports; assure patient
eligibility; document protocol deviations/violations; and manage adverse event reporting.
Oversee clinical monitoring from site qualification to site closure visits and assure
integrity of clinical data with respect to accuracy, accountability and documentation through
review of CRFs, source documents, and medical records. Evaluate and analyze clinical data;
provide input to Clinical Study Reports and Investigator Drug Brochures, including data
cleaning, listing review, and report writing; Travel to field sites to supervise and
coordinate clinical studies (25-50% travel).