Winship Cancer Institute of Emory University is seeking a Director, Clinical Trials
to provide expertise and strategic direction for the Clinical Trials Office (CTO), to include the National Cancer Institute (NCI)-designated Clinical Protocol Data Management operations. The Director provides expertise and direction for all aspects of cancer specific clinical research supported by the CTO. The incumbent will develop and maintain the Winship clinical trials infrastructure providing optimal support to the clinical research community for all cancer-specific clinical trials. The infrastructure will be consistent with the expectations of NCI-designated centers as outlined by the Cancer Center Support Grant (CCSG) guidelines. The incumbent will ensure all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all research programs within Winship are structured and supported to meet these expectations and requirements with a concentrated focus on increasing clinical trial accrual to meet the needs of the Winship catchment area. The Director oversees a team of highly skilled and efficient clinical research staff and leaders charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing robust training and education programming.
As the National Cancer Institute-designated Comprehensive Cancer Center for the state of Georgia, Winship is at the forefront of cancer research and discovery. Winship develops and delivers some of the world’s most effective ways to prevent, detect, diagnose, and treat cancer. Winship patients are seen by multidisciplinary teams that develop individualized treatment plans to meet each patient’s specific needs, including access to over 250 clinical trials. Our physicians are experts in specific cancers and use the latest in precision medicine, targeted therapies, and advanced technologies to achieve the best outcomes for their patients. The Winship Clinical Trials Office is currently composed of over 180 clinical research professionals divided into functional teams with a strong management team.
Reporting to Winship’s Senior Director, Research Administration and the Associate Director for Research, Clinical Trial Office, the Director will be responsible for the strategic planning, organization and oversight of the Winship CTO including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement.
Provides expertise, guidance, and oversight to the operational units within the CTO (clinical, regulatory, finance, quality, training, information systems, etc.)
In partnership with Winship leadership, oversees the fiscal control activities for the CTO; oversight of the development and maintenance of budgets, long-range financial and business planning, management of metrics to measure the ongoing status of the unit, and monthly operating reports.
In partnership with Winship leadership, creates and implements a comprehensive people strategy that defines roles and responsibilities, success measures, employee development, growth, and engagement.
Administrative management of the electronic systems utilized to monitor CTO performance and efficiency.
Oversee the development, implementation, and maintenance of SOPs to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the fiscal and scientific integrity of clinical trials activities.
Facilitate the strategic expansion of the Winship clinical trials programs across the Emory University system, the Winship Cancer Network and Affiliate sites in conjunction with center leadership.
Provide oversight for the development and generation of monthly reports including by not limited to CTO performance, accrual, monitoring, time to activation, audit visits, and financial performance. Ensure accuracy of clinical trials information in all CTMS, clinical trials databases, and tracking systems.
Ensure quality, timely, and accurate data and report submissions.
Represent the Winship CTO on university and health system committees and task forces as needed.
Serve as liaison to advance clinical trials interests including participation in community outreach.
Interfaces with the Emory University Office of Clinical Research to ensure timely, efficient, and accurate coverage analyses, budgets, and contracts are developed for all cancer-specific clinical trials, within the overall institutional guidelines and policies.
Provides direction regarding Winship’s perspective on overage analysis development in conjunction with Research compliance.
Provides oversight of the day-to-day operations of the Winship CTO.
Directs the administrative and financial requirement of the Winship CTO office to ensure success in all activities and to meet expected center growth models.
Provides oversight and ownership of CTO-based databases, metrics developments and data accuracy.
Works closely with the Winship Associate Director for Clinical Research to ensure alignment.
Liaise with Patient Finance to ensure appropriate payment and reimbursement designations are in place based on institutional compliance decisions, nationally recognized guidelines, and/or information from denials management records.
Master's degree in a health-related discipline or Business Administration and ten years of progressively responsible research, nursing, clinical trials or related experience which includes supervisory responsibility OR an equivalent combination of education, training and experience. At least 5 years of managerial experience. Documented successful research administration experience focused on managing a clinical trials function. Demonstrated leadership and budget management skills.