The Office of Research Integrity and Compliance in the Research Office at West Virginia University is seeking applications for a Human Research Protections Program Administrator. This position is responsible for human subject 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.
In order to be successful in this position, the ideal candidate will:
Manage the daily operational oversight of the Institutional Review Board programs, staff management and promote best practices in Human Research Subject Protections.
Collaborate with Health Science Center's key stakeholders in matters involving HRPP processes, subject informed consents, and ethical and regulatory boundaries of access to human data in clinical trials.
Provide strategic direction to ensure that the HRPP adheres to regulatory requirements and maintains comprehensive knowledge of such, and interpret and communicate regulations to researchers.
Manage, prepare and administer resources and enhance structures and processes to improve HRPP productivity and customer satisfaction while allowing world class research to expand.
Resolve questions or conflicts involving very complex research compliance issues.
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.
Oversee the maintenance of the HRPP Standard Operating Procedures, records and policies and procedures to ensure they are kept up-to-date and follow the best practices.
Coordinate and align an auditing and monitoring program for HRPP components that effectively integrate into the Quality Management System and Quality Systems Regulations.
Manage HRPP reliance and Central HRPP agreements and Memorandums of Understanding.
Provide training, guidance and consultation to students, faculty, investigators, and administrators and collaborate with all pertinent areas to garner support for best practices.
Create the structures and processes to enhance productivity to include metrics and regular reporting for workload volume and review timelines as well as other reports as needed or requested.
Provide guidance to the IO via the IRB Chairs concerning Board appointments to ensure committee membership adequately represents the scientific expertise necessary.
Master's degree required
Seven (7) years of progressive achievement in human subject protection research administration culminating in a significant HRPP leadership role
Five (5) years of experience in clinical research and/or regulatory affairs
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 and regulatory agencies on local, regional, national and international levels and provide/build excellent customer service relationships
Ability to work independently, organize and prioritize tasks and projects, and meet routine and pressure deadlines
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
CertifiedIRB Professional (CIP) required
At West Virginia University, we prideourselves on a tireless endeavor for achievement. We are home to some of themost passionate, innovative minds in the country who push their limits for thesake of progress, constantly moving the world forward. Our students, facultyand staff make this institution one of the best out there, and we are proud tostand as one voice, one university, one WVU. Find out more about youropportunities as a Mountaineer at http://hr.wvu.edu/.
West VirginiaUniversity is an Equal Opportunity/Affirmative Action Employer and therecipient of an NSF ADVANCE award for gender equity. The University valuesdiversity among its faculty, staff and students, and invites applications fromall qualified individuals, including minorities, females, individuals withdisabilities and veterans.
West Virginia University, founded in 1867, has a long and rich history as a public, land-grant institution. WVU encourages scholarship and offers high-quality academic programs while serving the state of West Virginia and the nation. WVU statewide includes campuses in Beckley, Charleston, Keyser, Martinsburg and Morgantown – which has been ranked as a #1 Small City in America. WVU is an R1 Doctora...l Research University (Highest Research Activity), one of only 115 nationwide. WVU offers 212 degrees throughout the 14 colleges and schools. Areas of specialty include STEM education, healthcare in Appalachia, shale gas utilization, radio astronomy and forensics. WVU researchers have helped confirm the existence of gravitational waves and uncovered diesel vehicle emissions discrepancies. Statewide, there are over 31,000 graduate and undergraduate students along with 190,000 alumni worldwide. WVU is reinventing West Virginia’s future by strengthening education, healthcare and broad-based prosperity.