This position, under the direct purview of the HRPP Executive Director, manages all activities related to a program for evaluation of human subjects research investigator performance, IRB performance, and for all internal and external summary reporting related to these activities. The position is responsible for identifying opportunities for improvement and for implementing strategies that drive increased compliance and transparency relative to these activities.
I. Develop and maintain the quality program for evaluating investigator and IRB performance. Develop and maintain complimentary plan for reporting of quality program activities and IRB metrics. Supervise and assign program staff to ensure completion of performance quality assessments as well as ad hoc reviews, verification and reporting of completion of any required corrective actions, collaboration with external stakeholders with respect to provision of data and/or reports. (55%)
Develop and maintain a human research investigator performance audit plan and manual
Develop and maintain a risk-based strategy for selection of studies for conducting investigator performance quality assurance audits. Included in this strategy will be identification and review of researchers with restrictions related to conducting human subjects research.
Audit plan must provide for annual review of the following
not less than 10% of greater than minimal risk studies actively enrolling or following participants
not less than 5% of not greater than minimal risk studies
studies for which review has been ceded to another IRB (that are actively enrolling or following participants)
Develop and implement a review and summary reporting process for clinical trial monitoring reports
Implement a quality assurance review of the consent process using direct observation and/or retrospective evaluations
Implement investigator self-evaluation tools to evaluate compliance
Provide direct assistance to investigators when requested by the IRB or when corrective/preventative strategies are needed to achieve or maintain compliance
Develop and maintain an IRB performance audit plan and manual based on best practice and guided by commitments previously made under the Advancing Human Research Protection implementation plan
Monitor information provided in routine reporting of IRB metrics and feedback from researchers to guide IRB performance activities including turnaround time, productivity and other measures of IRB staff performance
Review consistent and appropriate use of toolkit documents by IRB staff - including decisions made via the non-committee review process
Review compliance with toolkit documents related to documentation of all decisions including IRB minutes
Conduct targeted reviews of IRB performance to support quality assurance initiatives in the IRB as directed by the HRPP Executive Director or Chief of Staff
Identify and recommend quality improvement opportunities for IRB staff.
Ensure that program staff conduct additional audits if requested by the IRB
When investigator corrective action is required, supervise staff to assure research team follow up on investigator corrective actions
Ensure that program staff verify compliance with department specific (e.g. Psychiatry) requirements for external reporting
Ensure that requests for information from the Department of Internal Audits is provided by QA/QI program staff in a timely way
Ensure that all reporting commitments are met which include but are not limited to:
annual AAHRPP reporting
application for re-accreditation;
monthly reporting of metrics,
semi-annual and other annual requirements as outlined in reporting manual
Ensure that copies of all IRB reports to federal agencies are received by the QA/QI program and considered when conducting investigator and/or IRB performance activities
Develop reports reflective of progress toward quality improvement goals for the IRB or Chief of Staff
II. Maintain and transfer expert knowledge (20%)
Maintain currency with regulations (Common Rule, FDA regulations, ICH GCP guidelines) and best practices for HRPP QA/QI programs
Work with the HRPP Education and Outreach Coordinator to ensure that findings of the QA/QI program inform development of training objectives for investigators or for IRB staff
Serve as a knowledgeable resource for the HRPP
III. Direct and supervise staff or manage consultants (15%)
Lead and manage staff in the program ensuring that performance aligns with expectations and commitments, actively work to develop and maintain an atmosphere of collaboration, collegiality and mutual support
Engage consultants, as needed, to perform investigator performance audits – defining the scope of work and managing the agreement
IV. Represent the program internally and externally (5%)
Attend HRPP meetings including staff meetings, and HRPP Management Team meetings
Represent the program at quarterly HRPP Advisory Committee meetings
Attend national meetings as resources allow
V. Other duties as assigned (5%)
Some of the duties assigned by the Executive Director may, on occasion, be unrelated to the position described.
Requires BA/BS with at least 6 years of experience or advanced degree with 4 years of experience
Minimum 10 years of experience in a clinical research quality program with evidence of increasing responsibility
Minimum 5 years of experience as a team lead
Advanced knowledge of guidance and federal regulations to include: ICH GCP; 21 CFR Parts 50, 56, 312 and 812; and 45 CFR 46 Parts 46, 160 and 164.
Advanced knowledge of standards governing quality initiatives
Strong analytical skills, critical thinking, and problem solving skills
Proven ability to maintain attention to detail and confidentiality of sensitive information
Strong interpersonal skills to include: listening objectively and openly to ideas of others, managing conflict, and a desire to contribute to building an engaged and positive team
Excellent verbal and written communication skills
Skills in Microsoft Word, Excel and Powerpoint required
Ability to multi-task, work under conditions of stress, and meet deadlines
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive par...tnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
The mission of the University of Minnesota is deeply connected to the conduct of research. It is of critical importance to the reputation and future of this institution that we remain committed to the highest standards of research integrity in all work conducted in our institution.
The Human Research Protection Program (HRPP) provides support to the Institutional Review Board (IRB). Committee members and staff review all human subjects research conducted by University faculty, staff and students. HRPP also provides support to the research community to ensure ethical standards are met and that research complies with federal, state, local and University of Minnesota regulations.
The IRB reviews human subjects' research projects, working with investigators to ensure adequate protection and informed, uncoerced consent.