The HRPP Officer will serve as a member of a team of professionals employed to ensure that Mississippi State University maintains compliance with various federal regulations regarding research activities. Specifically, the HRPP Officer will administer the university-wide comprehensive Human Research Protections Program in a manner consistent with the Office of Human Research Protections (OHRP), Department of Health and Human Services (DHHS) regulations (45 CFR 46), Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards, and the Policy and Procedure statement on Human Subjects at Mississippi State University (http://www.msstate.edu/dept/audit/7903.html). The HRPP Officer will serve as OHRP's primary institutional contact person and will have administrative responsibility for the Institutional Review Board for the Protection of Human Subjects in Research (IRB).
This position reports directly to the Director of Research Compliance.
Duties and responsibilities include but are not limited to: • implementing University and Human Research Protection Program policies and directives; • educating members of the MSU community in order to establish and maintain a culture of compliance with Federal regulations and institutional policies relevant to the protection of human subjects; • directs supervision of HRPP staff members; • overseeing the review of protocol submissions, notifying PIs of IRB decisions, requesting additional information when required, and coordinating supplementary materials required by the IRB; • preparation of the University's annual reports for AAHRPP accreditation, OHRP Federalwide Assurance (FWA), IRB registration and status of the HRPP; • monitoring compliance, reporting non-compliance violations and adverse events, assessing effectiveness of the HRPP process, in addition to other quality assurance activities; • interpreting OHRP, FDA, FERPA and HIPAA regulations, and AAHRPP standards; • ensuring that all HRPP records are maintained appropriately; • reviewing, evaluating, and revising the MSU Operations Manual; • providing orientation and assistance to IRB members, evaluating IRB members, and assessing the composition of the IRB; • acts as designee for the IO in determining research engagement, institutional authorization agreements and unaffiliated individual investigators; • interacting with a wide variety if internal and external contacts such as Principal Investigators, Division and Department Heads, federal and state agency representatives, and sponsors of research.
Others activities related to the goals of the office may be assigned as necessary.
Mississippi State University is an equal opportunity institution. Discrimination in university employment, programs or activities based on race, color, ethnicity, sex, pregnancy, religion, national origin, disability, age, sexual orientation, genetic information, status as a U.S. veteran, or any other status protected by applicable law is prohibited. For more information, please contact the Office of Compliance and Integrity.
Master’s degree in a related field plus 4 years of relevant work experience -or- bachelor’s degree and 8 years of relevant work experience in a regulatory compliance or legal environment or related field. Sound knowledge of OHRP, DHHS regulations (45 CFR 46), Food and Drug Administration (FDA) regulations, AAHRPP standards, and the Health Insurance Portability and Accountability Act (HIPAA). Sufficient knowledge of regulations associated with other compliance areas covered by the office to make informed decisions regarding strategic planning and to ensure the application of consistent standards regarding these regulations.
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