Assistant Director - Office of Human Research Protections 16576
The Office of Human Research Protections (OHRP) at West Virginia University is seeking applications for an Assistant Director. This position reports to the Director and is responsible for developing and maintaining up-to-date programs for IRB policy, education, operations, and risk through staff support and regular review of SOPs, QIPs, training and accreditation process and metrics.
In order to be successful in this position, the ideal candidate will:
Assist as directed in management and oversight of WVU OHRP staff, external IRB review, full-board committee operations, and protocol review processes.
Develop operational strategies via gap analysis and through continuous and evolving plans ensure WVU is an example of a best practice organization.
Assist as directed with full-board committee management and protocol reviews. Maintain appropriate level of committee membership in different areas and ensure proper oversight of full board protocol reviews and post approval monitoring.
Assist as directed in development, review, amendment, and maintenance of Standard Operating Procedures (SOPs) and guidance documents to ensure compliance with international, federal, state, and local regulations associated with human subject protections, institutional requirements and AAHRPP accreditation standards.
Ensure up-to-date FWA and/or IORG submissions.
Develop and manage education and training initiatives for students, faculty, WVU OHRP staff, IRB committee members and other researchers. Mentor as appropriate.
Manage the Quality Improvement Program (QIP) designed to improve researcher compliance and knowledge.
Manage ongoing AAHRPP accreditation including reaccreditation, data collection and submission of annual reporting and other accreditation standards.
Assist as directed with OHRP projects as the human research protections expert in coordination with continuous improvement efforts.
Function as a Tier 2 resource for WVU OHRP staff to address complex questions, protocols, and issues.
Function as a Tier 3 facilitator for WVU OHRP when it involves external parties outside the IRB's scope and/or requires outside expertise as needed.
Assist in facilitation of IRB Advisory Groups designed to assess researcher and reviewer responses to WVU OHRP policy and process changes.
Assist as directed in development and management of a cohesive and compliant external reliance review process; manage relationships with internal and external entities and develop and maintain policies and procedures for external reliance.
Develop, maintain, and manage electronic and paper-based forms, content, and delivery via the web or other mechanisms.
Assist as a liaison between WVU, WVU Health Sciences and WVU Medicine and affiliates to enhance communications and facilitate smoother, more efficient, process flows related to IRB reviews and oversight.
Conduct any type of protocol reviews as needed.
Master's Degree or an equivalent combination of education and experience
Five (5) 5 or more years progressive achievement in a human subject protections research administration office
Two (2) or more years' experience working with clinical research and/or regulatory affairs.
Experience with all types of research reviews and oversight to include biomedical, social and behavioral, and clinical trials
Direct experience developing, drafting, and/or maintaining SOPs/IRB policies and procedures, and guidance documents to comply with international, federal, state, and local regulations associated with human subject protections, institutional requirements and AAHRPP accreditation standards
High level of regulatory expertise with ability to work effectively across a variety of human subject research types and settings
Direct experience working with principal investigators on the development, submission, and execution of clinical and/or biomedical research protocols
Direct experience managing all aspects of IRB committee meetings from beginning to end (pre-review, protocol assignment, agenda creation, meeting minutes, meeting administration and execution, processing post review, etc.)
Experience with external reliance agreements to include commercial IRB use, NCI IRB, IRB of Record, IAAs, sIRBs and local context issues
Proven track record in advanced program development and/or process improvement
Pragmatic, customer-centric approach balancing regulatory compliance requirements against practical needs and limitations
Demonstrated ability to lead dissimilar groups toward productive outcomes
Proven track record successfully leading people, processes, and projects
Experience developing and implementing novel, innovative practices in human subject research reviews and operations that maximize efficiency while ensuring compliance objectives
Proven ability to collaborate with faculty members and regulatory agencies on local, regional, national, and international levels and provide/build excellent customer relations
Substantial knowledge of FDA, OHRP, HIPAA, GCP and other regulations and guidelines pertinent to human research protections and IRB operations at an R1 institution
Mastery of written and verbal communication
Advanced technical skills
Biomedical and social, behavioral and education research (SBER) review experience
Experience working at an R1 institution of higher learning with an academic medical center
Experience with tissue banks, research/data repositories, genetic research
Program management, project management, process/continuous improvement, quality improvement experience with proven ability to develop and implement more efficient, effective, compliant, customer-centric operational solutions
Experience with e-consent use and implementation
Experience developing and implementing training for WVU OHRP staff, IRB committee members, and researchers (all levels)
Direct experience in auditing, monitoring, and/or quality improvement
Experience with Kuali Coeus (KC)
Experience with HIPAA hybrid entity model
Professional certification in a field related to human subject protections, clinical research operations, and/or healthcare research compliance awarded by groups such as Public Responsibility in Medicine and Research (PRIM&R), Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA), Health Care Compliance Association (HCCA) and/or other professional organizations of established size and credibility required. PRIM&R CIP highly preferred.
At West Virginia University, we leverage our talents and resources to create a better future for our state and the world. As West Virginia's land-grant university, WVU has three campuses that touch each corner of the state. The WVU System includes 518 buildings on 15,880 acres, Extension Service offices in all 55 counties, ten experimental farms and four forests.
From the groundbreaking R1 research of our flagship campus in Morgantown to the career-oriented programs of WVU Potomac State in Keyser to the technology-intensive programs at WVU Tech in Beckley -- the contributions of WVU employees directly impact the 1.8 million people of West Virginia every day, no matter their role or position.
Service, curiosity, respect, accountability, and appreciation are the core values that unite Mountaineers, inspiring one another to work tirelessly and support others as they seek to reach new heights. After all, when you're a Mountaineer, impossible is just another mountain to climb.
West Virginia University is proud to be an Equal Opportunity employer and is 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 applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
Job Posting: Mar 29, 2021
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes
Internal Number: 224883
About West Virginia University
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 Doctoral 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.