Assistant Director, Clinical Research Administration & Compliance
UF Health Cancer Center
June 13, 2018
$100,000 - $110,000 annually;
Full Time - Experienced
CCRP (Certified Clinical Research Professional)
This position is located in the University of Florida Health Cancer Center (UFHCC) Clinical Research Office (CRO). The Assistant Director, Clinical Research Administration & Compliance will oversee all cancer-related clinical research compliance operations at the UFHCC including management of the Quality Assurance program, education and training initiatives, as well as the Cancer Center’s internal review and oversight committees, including all staff involved in these processes. The incumbent will assist with provision and analysis of data to support metrics of CRO operations, assess educational needs and instruct staff on good clinical practices related to patient management, data quality and data management; develop and implement policies and procedures; and develop and maintain a manual of procedures.
Core Committee Oversight
In conjunction with the Director of the CRO, establishes the operational framework, goals and expectations for the Core Committees. Independently manages all daily operations of the unit including general oversight and facilitation of all DSG, SRMC and DISC meetings. Position is responsible for analyzing, creating, modifying, and implementing required policies and procedures to ensure committee functions remain in alignment with UFHCC and NCI expectations.
Leads all core committee responsibilities and functions include creating meeting agendas, developing complex correspondence to Principal Investigators (PIs), conducting follow-up activity on action items in a timely manner, outreaching to PIs and clinical research coordinators for research accrual information, and writing complex meeting minutes for scientific meeting deliberations. Tracks committee metrics to evaluate operational efficiency, identify opportunities for improvement, and comparison with national standards. Proposes and implements changes to workflows to meet operational goals and or gain efficiencies.
Works with leadership to identify and evaluate committee membership. Responsible for creating and implementing a training program for new and existing SRMC and DISC committee members to ensure all committee activities are being conducted in a consistent manner that is in compliance with UFHCC policies.
This individual must verify the accuracy of clinical trial information in the clinical trial management system, OnCore, and adhere to both institutional policies and National Cancer Institute requirements. Ensures that all committee reviews of protocols are completed in a timely fashion and accurately documented.
Provides oversight to all CRO managed compliance divisions ensuring that systems are in place for the effective, efficient, and accurate conduct of clinical trials. Manages resolution of problem-solving for issues arising from the conduct of clinical research activities. Promotes a vision and model for compliance and standards across the Cancer Center, fostering commitment, cooperation, and positive communication. May involve departments within the College of Medicine, UF Health Shands Hospital, Faculty Group Practice and other entities at the UF Health Science Center.
In conjunction with the CRO Director and Assistant Director of Clinical Research Operations, establishes and manages a written system of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with UFHCC policies and procedures, NCI requirements, external regulatory agencies and central research administration offices. Interprets and ensures proper execution of institutional policies and recommends policy changes as necessary. Manages SOPs templates, and creates guidelines and processes for additional SOP development. Responsible for implementing SOPs within the compliance divisions.
Ensures compliance with all applicable regulations for the conduct of clinical research trials, and adherence to Good Clinical Practice.
Leads the QA team in coordination of all external regulatory and quality audits and inspections of CRO managed studies, identifying and resolving compliance issues and concerns, developing and implementing quality improvement plans to mitigate future risk and reporting on research compliance activities. Ensures the timely development of audit schedule, oversees and provides necessary support for the preparation and conduct of audits undertaken by the Sr. Research Auditor and relevant staff. Directs internal audits of all required UHFCC committee functions; manages committee memberships and attends committee meetings as required.
Performs evaluations of committee metrics and reports committee performance to UFHCC and CRO leadership on a regular basis.
Supervises the oversight of the University of Florida’s NCTN Cooperative Group memberships (CTSU, NRG, SWOG). Ensures that the UFHCC CRO remains in compliance with all cooperative group policies and procedures. Tracks and ensures closure of all clinical trial corrective action plans.
Responsible for overall management of related center or group meetings, as well as meetings of applicable scientific advisory councils. Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics that drive improvement. Serves as research team liaison, providing communication and consultation services as needed. Maintains records, files and data for research regulatory and quality assurance efforts.
Serves as a regulatory liaison with institutional, local, state and federal external agencies, communicating directly with agency personnel as necessary. Maintains up to date knowledge of all relevant laws, regulations, and guidelines for the conducting of clinical trials and protection of human research subjects.
Serves as a liaison between the CRO and external oncology providers, and other agencies and departments. Maintains regular contact and exchange of information with partners and other external entities in order to fulfill the clinical and research obligations of the CRO. Develops and maintains other relationships as warranted to benefit the CRO. Serves on taskforces for special projects for the CRO.
Education & Training
Directs the development of course materials, both in person and web-based, and the creation of curricula for new and existing faculty utilizing CRO services and CRO research staff. The AD will additionally oversee the provision of ongoing research education and training and assess the training needs of clinical and laboratory research personnel, using these findings to inform and direct the development of additional courses, materials, and policies as necessary for compliance. Evaluates existing clinical education programs, collaborating with the Director of the CRO and Assistant Director of Clinical Research Operations to implement necessary changes to maintain and improve systems.
Oversee tracking of all required reports, such as human subjects training, Good Clinical Practice, and all institutional required trainings, and other documents related to research training for CRO staff and faculty.
Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics that drive improvement. Serves as research team liaison, providing communication and consultation services as needed. Maintains records, files and data for research regulatory and quality assurance efforts.
Directly supervises assigned staff, including all staff assigned to the Core Committee, QA/QC, and education teams. Ensures success of the unit by monitoring staff productivity, establishing performance goals, and training or coaching staff as needed. Is responsible for supervising, administering, and achieving operational goals and objectives for implementation within their assigned unit. Serves as backup for staff when on leave, during vacancies, peak times, etc.
Approves bi-weekly time reporting for employees in the Compliance unit. In conjunction with the CRO Director and Human Resources, participates in the recruitment and onboarding of new staff and in staff performance appraisals. Mentors staff and provides clear, measurable performance expectations. Completes employee evaluations. Collaborates with Human Resources Manager and CRO leadership team to develop and update position descriptions. Collaborates with support staff to implement and change policies and/or procedures.
Implements continuous process improvement across all trial types. Identifies operational problems, issues and barriers across research projects with input from investigators, research team members, and sponsors; communicate patterns and trends to CRO Director as appropriate; supports efforts to develop and implement process/system improvements. Process improvement initiatives can be related to but are not limited to: coordination of staff tasking and workload analysis, streamlined project assignment and delegation procedures, creation of staff accountability and performance evaluation through process improvement. Communicates any CRO updates and process changes to relevant faculty and staff.
Participates in data reporting to support CCSG submissions.
Master’s degree in appropriate area of specialization and two years of appropriate experience; or a bachelor’s degree in appropriate areas of specialization and four years of experience.
Prior Oncology clinical trials experience and working knowledge of NCTN cooperative group system is required.
Recent experience (within the past 5 years) at a NCI designated or emerging center is highly preferred.
Experience with monitoring and/or auditing.
Research certification (ACRP/SOCRA)
Experience with Excel, PowerPoint and Word.
Must effectively work independently, interact professionally, interpret complex policies and procedures and possess effective technical writing, impeccable organizational skills and attention to detail
Internal Number: 507590
About UF Health Cancer Center
At the UF Health Cancer Center our mission is to prevent, detect, treat, and ultimately cure cancer while addressing the unique challenges of the cancer burden faced by the population we serve. Whether working directly in clinical trials with our faculty researchers and patients or operating behind the desk in administration, each of our employees has a critical role to play in the success of our Center and the discoveries that are made here.
The Cancer Center serves as the nucleus for the diverse institutional programs of research, education, and clinical approaches that are necessary to improve cancer outcomes. With more than 250 researchers and clinicians at the University and UF Health conducting research for the prevention, early diagnosis, and treatment of cancer our collaborative research model encourages the transition of basic laboratory findings to novel curative and preventative therapies. This multidisciplinary membership is our strength, and our net is cast wide. Researchers are drawn from 69 departments and 11 colleges across the University and collaborate with dozens of other UF multidisciplinary centers and institutes—including the McKnight Brain Institute, Prot...on Therapy Institute (one of only seven such facilities in the nation), Genetics Institute, Clinical and Translational Science Institute, Institute on Aging, and the Emerging Pathogens Institute, among others.