Senior Director, Clinical Trials- Winship Cancer Institute

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About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient's needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope. For more information, visit winshipcancer.emory.edu.

Winship is Seeking Qualified Candidates for the Senior Director, Clinical Trials Position

The Senior Director of Clinical Trials for the Winship Cancer Institute (Winship) provides expertise and strategic direction for the Clinical Trials Office (CTO) to include the National Cancer Institute (NCI)-designated Clinical Protocol and Data Management operations. Provides expertise and direction for all aspects of cancer-specific clinical research supported by the CTO. Develops and maintains the Winship clinical trials infrastructure providing optimal support to the clinical research community for all cancer-specific clinical trials. Ensures 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. 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. Has responsibility 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. Identifies operational parameters and requirements established by local, state & federal laws, and participates in the formulation of general operating policies; implements policy and develops appropriate procedures for all Winship sites, affiliate and Network sites. Integrates the CTO management team to promote more efficient and effective clinical research operations. Provides leadership and guidance for day-to-day activities of the CTO. Serves as an expert liaison to investigators and disease working group members to advance the quality and efficiency of clinical research. Provides expertise, guidance, and oversight to the operational units within the CTO (clinical, regulatory, protocol review and monitoring, data safety monitoring, quality, training, information systems, etc.). In partnership with Winship leadership, oversees the fiscal control activities for the CTO; has 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. Interacts with pharmaceutical and clinical research organization leaders to promote the Winship CTO and gain access to appropriate clinical trials; interacts with faculty, staff, and other cancer-related organizations to raise awareness of clinical trial offerings. Organize and run meetings with stakeholders (disease working group leaders, CTO management team, CTO staff meetings, attend leadership meetings with clinical research leadership, accrual oversight committees and organize yearly retreat to define metrics and targets for the following year). Has administrative management of the electronic systems utilized to monitor CTO performance and efficiency. Oversees 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. Provides oversight of all sponsored audits (federal, national, cooperative groups, industry etc) and ensures corrective action plans and necessary task forces to implement system wide changes. Participates in audit debriefings, review all audit / monitoring visit reports, and collaborates with the CTO management team to develop, implement, and monitor corrective action plans; and communicate these plans with Winship leadership to determine best methods for disseminating communications regarding these corrective action plans with faculty and clinical staff. Organize quarterly grand rounds for wider dissemination of these audit findings to CTO staff, PIs and other study personnel. Facilitates the strategic expansion of the Winship clinical trials programs across the Emory University system, the Winship Cancer Network, Affiliate sites, and across the state of Georgia in conjunction with center leadership. Representative of Commission on Cancer (Coc) for Clifton and ESJH, Grady, WEM and EJC. Coordinate and oversee NCTN sites that are sponsored by Winship. Works closely with leadership to develop the necessary infrastructure and training necessary to implement clinical trials in the community setting. Provides oversight for the development and generation of monthly reports including but not limited to CTO performance, accrual, monitoring, time to activation, audit visits, and financial performance. Works with informatics team to generate monthly reports for individual teams and the CTO. Ensures accuracy of clinical trials information in all CTMS, clinical trials databases, and tracking systems. Ensures quality, timely, and accurate data and report submissions. Represents the Winship CTO on university and health system committees and task forces as needed. Serves as a liaison to advance clinical trials interests including participation in community outreach. Collaborates with community outreach and engagement programs for broader implementation and wider accessibility of clinical research to the catchment area. Represents the Winship CTO at the American Associate for Cancer Institute's Clinical Research Initiative through participation in national working groups and committees. Interfaces with the Emory University Office of Clinical Research (OCR) 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. Works with OCR to develop programs that enhance CTO operations through training and provides CTO staff opportunities to be involved in training. 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. Works with the informatics team to implement innovative software / AI solutions to improvise CTO operations and workflows. Directs the administrative, staffing 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. Participates with Associate Director of Clinical Research, Chief Administrative Officer and Winship leadership in the development of strategic plan for growth of the clinical research enterprise. Actively engages in the preparations for the written application for the P30 Cancer Center Support Grant. Liaises with Emory Healthcare and Woodruff Health Sciences Center 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. Performs related responsibilities as required.

Minimum Qualifications

• Master's degree in a health-related discipline or Business Administration and 10 years of progressively responsible research, nursing, clinical trials or related experience which includes supervisory and managerial responsibility
• OR an equivalent combination of education, training and experience.
• Documented successful research administration experience focused on managing a clinical trials function.
• Demonstrated leadership and budget management skills. Experience with the National Cancer Institute (NCI)-designated Clinical Protocol and Data Management operations is preferred.

Additional Details

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone : 404-727-9867 (V) | 404-712-2049 (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.