Dept Number/Name: 0-7910-000 / Research Integrity &Compliance
College Division: Research-Integrity and Compliance
Salary Plan: Administrative
Job Code/Title: 9546 / Assistant Director
Hiring Salary/Salary Range: $85,000 - $105,000
Position Schedule: Hybrid (Monday - Friday 8:00am - 5:00pm)
Position Number: 00019119
ORGANIZATIONAL SUMMARY:
Research Integrity & Compliance (RIC) is a department within the USF system vice presidential area, Research & Innovation, and reports through a Director and an Assistant Vice President and a Vice President. The main function of RIC is to ensure compliance with federal and state regulations and institutional policies pertaining to the responsible conduct of research. The department is responsible for such programs as Human Research Protection, Animal Safety, Boating Safety & Scientific Diving Safety, Radiation Safety, Biosafety, Conflicts of Interest in Research, Export Controls, and HIPAA, among others. RIC has 35 employees and an annual budget of over $3 million. Clients are USF research faculty, students, and staff, as well as researchers at affiliated institutions.
POSITION SUMMARY:
This position has delegated signature authority for the following programs: Human Research Protection, Research Privacy, Investigational Drug/Device, and Quality Assurance/Quality Improvement. The Assistant Director is responsible for ensuring compliance with all Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and for maintaining accreditation. The Assistant Director acts on behalf of the Director in his/her absence. The Assistant 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 Vice President for approval each year.
RESPONSIBILITIES:
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 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 USF.
MINIMUM:
This position requires a Bachelor's degree from a regionally accredited institution with a minimum of four years related exempt experience, including two years of experience managing exempt level employees.
PREFERRED: A master's degree in health administration or similar field relating to health care research and/or human subjects research administration/management. Four years’ experience overseeing human subjects research in a university or healthcare setting. Expert knowledge of the Common Rule; FDA regulations governing clinical trials; and HIPAA Privacy regulations. Four years of management experience with knowledge to maintain a productive office environment. Strong problem solving and critical thinking skills while exercising sound judgement. Familiarity with business operations and strategies. Familiarity and experience with the federal regulations in the area of objectivity in research. Experience using data management software. Experience with developing and managing research billing processes. CIP (Certified IRB Professional) or other related certification.
USF Research, Innovation & Economic Development (USFRI) is charged with the central administration and oversight of the USF System research enterprise. USFRI promotes USF research; stimulates economic development; provides services and assistance to facilitate faculty, staff, and student research efforts; ensures compliance with research-related laws, regulations, and policies of federal, state, sponsoring agencies and organizations, and the university; and provides for the protection and promotion of intellectual property generated by USF System employees.Research Integrity & Compliance (RIC) is a unit within the USF system vice presidential area, Research & Innovation. The main function of RIC is to ensure compliance with federal and state regulations pertaining to the responsible conduct of research. RIC is responsible for such programs as the Human Research Protection, Animal Safety, Diving Safety, Radiation Safety, Biosafety, Scientific Misconduct, Conflicts of Interest in Research, and HIPAA, among others.
