Responsible for human subjects protection programmatic vision and effective implementation of that vision as well as development and management of campus-wide regulatory compliance programs ensuring adherence with federal regulations. Responsible for daily operational oversight of the Institutional Review Board (IRB) programs, staff management and promoting best practices in Human Research Subject Protections. Provide mentorship and training to Human Research Protections Program (HRPP) staff and the research community.
Collaborates synergistically with Health Sciences Center’s (HSC) key stakeholders (CTSI, Cancer Center, CTRU, CPRC and others) in matters involving HRPP processes, subject informed consents, and ethical and regulatory boundaries of access to human data in clinical trials.
Duties and Responsibilities
Provide strategic direction to ensure that the HRPP adheres to the regulatory requirements defined by the International, Federal, State, local and the University statutes as well as profession’s best practices and that the needs of the research community are appropriately addressed. Maintain comprehensive knowledge of existing and forthcoming international, federal, state, local and University regulations, laws, policies, and ethical principles; interprets and communicates regulations to researchers accurately and with clarity and thoroughness.
Responsible for managing, preparing, and administering resources. Review recommendations for human research compliance programs. Enhance structures and processes to improve HRPP productivity and customer satisfaction while allowing world class research to expand.
Responsible for resolving questions or conflicts involving very complex research compliance issues and providing clarifications regarding regulatory or policy matters related to the research review system. Lead collective problem solving by fostering discussion and interaction between affected constituents to achieve resolution of challenges.
Assure that process and systems in use for the review and oversight of human subject research are cutting-edge and consistent with industry best practices. Identify needs for and develop additional policies, practices or initiatives to enhance the efficiency of the human subject research review path while maintaining compliance with federal and state regulations.
Responsible for proper record keeping of all HRPP related documents. Communications, meeting minutes, and archived materials electronically and/or in hard copies in accordance with Good Documentation Practices.
Oversee the maintenance of the HRPP Standard Operating Procedures (SOPs), policies and procedures to ensure they are kept up-to-date and follow the best practices. Identify potential regulatory issues with the human subject research protocols and appropriately communicate and document with the Principle Investigators. Based on identified issues, revise current SOPs and/or implement new SOPs and processes to assure compliance with regulatory and accreditation requirements.
Coordinate and align an auditing and monitoring program for HRPP Components that effectively and synergistically integrates into the Quality Management System (QMS) and Quality Systems Regulations (QSR).
Manage HRPP reliance and Central HRPP agreements and Memorandums of Understanding (MOUs), as well as the front-end and back-end processes that support these agreements.
Provide guidance and consultation to students, faculty, investigators, and administrators regarding current issues and ethical concerns in human subject protection for new or continuing protocol submissions. Provides relevant training through one-on-one and group sessions related to IRB procedures.
Collaborate with all pertinent areas to garner support for best practices in both Research and Compliance. Proactively engage stakeholders to formulate strategies to resolve complex long and short term program wide issues. Liaison between Office of Research Integrity and Compliance (ORIC) and the University research community; as well as relevant university committees/constituents in the implementation of policies and international/federal regulations.
Monitor and analyze new legislation, federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community. Revise existing institutional policies and procedures to assure compliance with evolving federal regulations.
Create the structures and processes to enhance productivity. Develop metrics and regular reporting for workload volume and review timelines as well as other reports as needed or requested. Assist in preparation of reports and correspondence related to HRPP activities. Provide assistance in the performance of internal quality improvement activities.
Provide guidance to the IO via the IRB Chairs concerning Board appointments to ensure committee membership adequately represents the scientific expertise necessary.
A master’s degree required.
Certified IRB Professional (CIP) required.
7 years progressive achievement in human subject protection research administration culminating in a significant HRPP leadership role.
5 years of experience in clinical research and/or regulatory affair.
Extensive experience with Central IRB/HRPP agreements, reliance agreements, IAA and DATA repositories.
Experience with novel and innovative practices in Human Subject Research Reviews.
Prior Biomedical or Social and Behavior research experience preferred.
Detailed working knowledge of regulatory requirements for the protection of human subjects of both biomedical and behavioral research.
Proven ability to collaborate directly with faculty members, regulatory agencies on local, regional, national and international levels and provide/build excellent customer service relationships.
Ability to work independently, to organize and prioritize tasks and projects and to meet routine and pressure deadlines.
Excellent written and oral communications skills.
Demonstrated ability to work effectively with individuals at various organizational levels and to communicate with tact and courtesy while maintaining confidentiality.
Substantial knowledge of 21 CFR 11, 50, 56, 312, 812, IHC/GCP-E6, 45 CFR 46, AAHRPP accreditation standards and processes and any other applicable laws.
Knowledge of social science research methodologies.
Ability to interpret research protocol information in relation to federal regulations and guidelines, and internal University policies and to formulate broad policy recommendations for the organization
Familiarity with computerized databases and electronic management software.
West Virginia University is an Equal Employment Opportunity/Affirmative Action Employer. Under-represented class members are encouraged to apply. This includes: minorities, females, individuals with disabilities and veterans.
At West Virginia University, we pride ourselves on a tireless endeavor for achievement. We are home to some of the most passionate, innovative minds in the country who push their limits for the sake of progress, constantly moving the world forward. Our students, faculty and staff make this institution one of the best out there, and we are proud to stand as one voice, one university, one WVU. Find ...out more about your opportunities as a Mountaineer at http://hr.wvu.edu/.
West Virginia University is an Equal Opportunity/Affirmative Action Employer and the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff and students, and invites applications from all qualified individuals, including minorities, females, individuals with disabilities and veterans.