Under the direction of the Senior Director, the Associate Director will contribute to the support of breast and colorectal cancer research and the management of clinical trials by assisting with the planning, development, management and coordination of all operational aspects of Phase I, II, and III clinical trials, selection and implementation of Industry Trials Site Membership, and liaison with pharmaceutical companies, investigators, program coordinators, and other organizations.
• Assists the Director in the management of all clinical aspects of the project, including: assesses operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics
• Participates in the selection and management/oversight of external vendors and develops vendor specifications; reviews vendor budgets, and metrics
• Assists in the oversight of the development of study-specific training and leadership to clinical research staff including CRO, CRAs, sites and other contract personnel
• Works with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
• Ensure the success of clinical trials through selection of appropriate sites, executing successful investigator and site training, implementing effective recruitment/ retention strategies, and communicating with sites, pharmaceutical companies and other organizations
• Bachelor’s degree in nursing required
• Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
• Five years research experience in a health care setting with management experience preferred
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
Location: Pittsburgh, PA