This position will assist in the ongoing conduct of the U of M HRPP QA/QI program, evaluating clinical investigator performance and compliance with policies and procedures, Good Clinical Practice and applicable regulatory requirements. The primary purpose of the work performed is to conduct clinical trial inspections, perform risk assessments, analyze trends including root cause, and report and disseminate information to key stakeholders to enhance the protections of human research participants at the University of Minnesota.
1. Quality assurance inspections of investigator compliance:
- Plan, develop and conduct on-site inspections of clinical research in accord with QA/QI program plans including execution of appropriate proportion of inspections to meet program goals and comprehensively assess risk. The plans and procedures are to be developed using the program’s risk-based methodology, focusing inspection efforts on those activities creating the greatest risks.
- Investigate compliance breaches. Gather relevant information, assess impact to the University, determine steps to mitigate risk, and report findings. Communicate regulatory changes, update procedures according to best practice and act as a resource to colleagues and researchers in the area of research compliance.
- Evaluate clinical investigator adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site inspections.
- Assist in resolving any issues in order to ensure compliance and enhance the protection of research subjects.
- Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with investigators, when appropriate, to resolve data inconsistencies.
- May review protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepared study-related documents and templates, as requested by the QA/QI Program and/or IRB.
- Authorized to request inspections due to data integrity concerns.
- Communicate the results of work performed, using both verbal and written skills. This will include:
- Developing and documenting findings and recommendations in a manner that allows for proper review and assessment of the risks identified and the conclusions drawn.
- Meeting with the investigators and/or IRB to discuss both the preliminary, when applicable, and final results.
- Drafting the initial inspection report document.
- Using appropriate judgment in evaluating the significance of audit findings
- Ensuring recommendations made are both actionable and in alignment with regulation and guidance governing the protection of human research subjects.
2. In house inspections and compliance assessments:
- Lead, plan, develop and conduct internal evaluations of clinical investigator compliance; collect, and analyze data from a variety of sources and teams. Develop comprehensive reports of results for dissemination to internal and external compliance entities.
- Work collaboratively with researchers and HRPP staff to develop and lead the implementation of compliance efforts and support strategic initiatives.
- Provide advice and expert knowledge on regulatory requirements and UMN HRPP policies to IRB Committee members, IRB staff, researchers and study staff
- Attend IRB meetings to maintain consistency between the IRB review and the QA/QI program.
- Assist with external quality and regulatory reviews of the HRPP as well as collaborate with other organizations (internal and external) in support of the HRPP mission
3. Program Development and Compliance Results Evaluations:
- Analyze and interpret policies and procedures, federal regulations, GCP compliance, guidance documents and accreditation standards for the protection of human subjects. Expert knowledge of all regulatory requirements related to the conduct of clinical research.
- Work with QA/QI staff to analyze overall findings for trends and key process failures, providing communication to the HRPP for training initiatives to resolve/address adverse trends.
- Lead and manage the creation, development, and maintenance of policies, procedures and tools related to clinical inspections.
- Initiate and participate in cross-functional problem solving projects; establish and maintain records of compliance activities
- Serve as mentor for junior CRAs and other staff of the HRPP QA/QI program.
- Assist the QA/QI Program in annual evaluation of related program activities and risk stratification for study clinical trial inspection selection. In collaboration with program leadership, plan and develop the overall clinical inspection plan and specific tests and procedures to be used for inspections of University units and processes. The plans and procedures are to be developed using a risk-based methodology, focusing our efforts on those activities creating the greatest risks to the institution.
4. Other Duties as assigned:
- Attends study-related, and departmental meetings, as required.
- Maintain appropriate credentialing
- Maintain expert knowledge of clinical monitoring techniques, requirements and guidance.
- Collaborate with internal compliance functions to enhance research compliance at the University of Minnesota.
- Conduct follow-up work to determine the status of prior recommendations made to management.
- Complete training and other activities to maintain and enhance professional skills, credentials and abilities.
- Serve as a resource for other QA/QI staff auditors.