Senior Protocol Coordinator
CurrentThis role focuses on serving as the protocol document specialist within the clinical trial study team. My day-to-day activities include managing the development of all documents relating to clinical research protocols in conjunction with study doctors, statisticians, and researchers, coordinating all internal and external review and approval processes throughout the length of a trial (from early study concept to study closure), establishing and communicating clear study development goals and deadlines to study chairs, pharmacists, statisticians and others in order to ensure study activation within Operational Efficiency Working Group (OEWG) timelines, designing therapy delivery maps consistent with the treatment plan outlined in the protocol, maintaining internal study records and tracking important study events, reviewing Case Report Forms (CRFs) for consistency with the protocol document and to ensure specific requirements of the protocol are met, delivering a final research document that incorporates all clinical details needed to treat patients and answer study questions, communicating with and facilitating communication between study chairs, study committee members, scientific committee chairs, institutional CRAs and other cooperative groups, amending the study documents as necessary, and drafting informed consent documents and youth information sheets.