This position has delegated signature authority for the following programs: Human Research Protection, Conflicts of Interest, Research Privacy, Investigational Drug/Device, and Quality Assurance/Quality Improvement. The Associate Director is responsible for ensuring compliance with all Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and for maintaining accreditation. The Associate Director acts on behalf of the Director in his/her absence. The Associate Director is also responsible for personnel assigned to the above programs. The position is instrumental in developing the department's budget and, with the Director, presenting it to the Senior Associate Vice President for approval each year.
Manages and oversees the USF System Human Research Protection Program (HRPP). Interprets and implements federal regulations, Florida statutes, Board of Governor regulations, and University regulations and policies regarding the protection of human subjects in research. Serves as the primary resource for regulatory and ethical guidance, providing direction for Institutional Review Board (IRB) members, investigators, IRB managers and staff, institutional officials, and the research community. Serves as a member of various IRBs as appropriate and ensures IRB rosters are compliant with the federal Office of Human Research Protections (OHRP) and U.S. Food and Drug Administration (FDA) requirements for membership. Oversees FDA and/or OHRP audits or investigations of noncompliance. Coordinates the process for accreditation from the Association for the Accreditation for Human Research Protection Programs (AAHRPP). Manages site visit preparation and annual reports to maintain accreditation.
Ensures standards are upheld and adjustments are made and approved by AAHRPP, when appropriate. Manages program reporting, budget, cost analysis, training, and personnel.
Manages the Quality Assurance/Quality Improvement (QA/QI) Program, which is part of the Human Research Protection Program (HRPP) and ensures compliance with the implementation of human research protocols. Ensures compliance with federal regulations, state law, and University policies related to the conduct of human subjects research. Manages the program reporting, budget, cost analysis, and personnel.
Manages USF System Conflicts of Interest (COI) in Research Program in accordance with federal agency regulations. Ensures a comprehensive review of financial interest disclosures. Develops, implements, and evaluates policies and procedures; grants exceptions. Oversees related training programs. Oversees investigations of noncompliance and resolves issues. Oversees the development and monitoring of management plans, working with Investigators and department chairs/deans. Serves as the Responsible Official for reporting Financial Conflicts of Interest to federal agencies and sponsors. Manages the program reporting, budget, cost analysis, and personnel.
Manages the HIPAA Privacy Program for USF System Research in accordance with federal regulations. Develops and implements policies and procedures, granting exceptions when appropriate. Serves as a liaison to the Institutional Research Board (IRB) and affiliates. Serves as a liaison to research investigators, various University programs and others. Oversees education and training. Investigates issues of noncompliance and engages with the appropriate committees and departments to report issues of noncompliance. Manages the program reporting, budget, cost analysis, training, and personnel.
Manages the Investigational Drug/Device Program to ensure compliance with the regulations of the Food and Drug Administration (FDA). Oversees education and training programs on regulations regarding the application of Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations. Assists with the application process and ensures compliance with reporting requirements. Responds to requests from the FDA regarding IND/IDE applications. Responds to inquiries from the Institutional Review Board regarding IND/IDE applications and ensures compliance with the regulations. Manages the program reporting, budget, and personnel.
Assists the Director as needed with oversight and management of other compliance programs, such as Export Controls or Biosafety. Assists the Director with overall departmental operations, including policies and procedures, budgets and cost analysis, personnel, and compliance reporting. Represents the Director and the Assistant Vice President at meetings or on workgroups. Remains current in regulatory matters by attending and presenting at professional conferences and through professional memberships.
Other duties as necessary to fulfill the mission of the department and the USF System.
This position requires a Bachelor's degree from a regionally accredited institution with a minimum of five years related exempt experience, including two years of experience managing exempt level employees.
A master's degree in health administration or similar field relating to health care research and/or human subjects research administration/management. Seven years of management experience. Familiarity and experience with the federal regulations in the area of objectivity in research. Experience using data management software.
Internal Number: 25140
About University of South Florida
The University of South Florida System is a high-impact, global research system dedicated to student success. The USF System includes three institutions: USF; USF St. Petersburg; and USF Sarasota-Manatee. The institutions are separately accredited by the Commission on Colleges of the Southern Association of Colleges and Schools. All institutions have distinct missions and their own detailed strategic plans. Serving over 48,000 students, the USF System has an annual budget of $1.6 billion and an annual economic impact of $4.4 billion. USF is a member of the American Athletic Conference.
With more than 16,000 employees in the USF System, the University of South Florida is one of the largest employers in the Tampa Bay region. At USF you will find opportunities to excel in a rich academic environment that fosters the development and advancement of our employees. We believe in creating a talented, engaged and driven workforce through on-going development and career opportunities. We also offer a first class benefit package that includes medical, dental and life insurance plans, retirement plan options, tuition program and generous leave programs and more.