Senior IRB Analyst

The Hennepin Healthcare Research Institute (HHRI) is inviting applicants to apply tor our full-time opening for an experienced Institutional Review Board (IRB) Analyst to complete the multi-disciplinary team that supports the research being conducted at Hennepin Healthcare. Please submit a cover letter along with your resume describing your qualifications.

This is a hybrid role requiring a periodic onsite presence in downtown Minneapolis, MN.

POSITION SUMMARY:

The IRB Senior Analyst has in-depth knowledge and understanding of Federal Regulations pertaining to human research and has experience applying regulations to IRB submissions for all types of category determinations (exempt, expedited, convened IRB review, not research, not engaged in research) and for all levels of IRB review (pre-review, re-review, clarifying issues, post meeting, non-committee review) to ensure adherence to regulatory and ethical standards. The Senior IRB Analyst supports Human Research Protection Program (HRPP) leadership to manage processes for Hennepin Healthcare research involving human subjects to ensure that it is conducted in a manner that protects the safety, rights, and welfare of research subjects. The Senior IRB Analyst will support compliance with institutional SOPs and international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research.

This position works closely with HRPP leadership to assess and implement institutional policies, guidelines, and procedures to ensure compliance with international, federal, and state regulations and ethical principles related to research involving human subjects.

ESSENTIAL JOB FUNCTIONS:

The Senior IRB Analyst serves as a key liaison with principal investigators and their designees to develop protocols and related materials and provide direction to facilitate IRB review of research involving human subjects. The Senior IRB Analyst identifies potential regulatory issues, provides guidance regarding IRB processes and how to navigate the Cayuse submission system. The Senior IRB Analyst also coordinates review activities with IRB reviewers for convened and expedited reviews and serves as a key resource regarding regulatory considerations and review procedures. The Senior IRB Analyst serves as a member of the IRB and conducts certain expedited IRB reviews of research involving human subjects, in addition to determinations of exemption, not research, and non-engagement. The Senior IRB Analyst may facilitate administration of IRB meetings. In collaboration with HRPP leadership, the Senior IRB Analyst develops and manages educational materials/presentations for the research community and research quality assessment tools/measures.

HRPO support

• Collaborate with HRPO staff to establish and refine workflow and operations
• Routinely provide support to IRB leadership and members
• Provide backup to HRPO staff as needed
• Support HRPO resource gallery management (e.g., SOPs, guidance documents, templates, forms, reviewer worksheets)
• Provide expertise on regulatory information regarding human research and the electronic IRB submission system
• Serve as a resource regarding ancillary processes related to IRB oversight

IRB assessments and reviews

• Collaborate with researchers to prepare protocols and supporting materials for IRB submission
• Develop and implement research quality assessment tools and measures
• Process submissions, including:
• Appropriately assign category determinations and/or level of review to submissions
• Conduct pre-reviews to ensure timely processing and that submissions conform with HRPP requirements and are reviewer-ready
• Provide pre-review feedback to investigators regarding submission completeness, compliance with appropriate regulations, IRB guidelines and institutional policies
• Develop and manage training of new and existing IRB members and strategies to engage all IRB members in the review process
• Anticipate regulatory issues for which IRB members may need specific information (e.g., IND/IDE submissions)
• Assign reviewers to submissions or components of submissions based on their area(s) of expertise and experience as an IRB member; oversee review status
• Generate agendas for IRB meetings based on knowledge of scientific aspects of the research submissions to be reviewed, as well as regulatory requirements and the expertise/role of each member
• Provide technical assistance as needed to IRB members to support their reviews using the electronic IRB management system
• Operate the electronic IRB management system during convened meetings to:
  • Confirm and monitor IRB member meeting attendance to ensure quorum
  • Record determinations made by the convened IRB
  • Capture relevant discussion items for meeting minutes and investigator communications
• Generate IRB meeting minutes
• Develop and/or support the creation of concise and detailed IRB review results in a timely manner for investigators and others as needed to ensure that reviewer/committee concerns, questions, and rationales are appropriately communicated
• Evaluate appropriateness of investigator responses to IRB communications; request additional material/information as needed

Special projects

• Develop and manage HRPO educational materials and presentations for the research community
• Provide support to the Office of Education and Quality in Clinical Research (OEQCR) for HRPP education and outreach activities, as needed
• Support HRPP-related activities (e.g., maintaining AAHRPP accreditation) as requested
• Identify professional development opportunities

EMPLOYMENT STANDARDS:

Education/Experience:

Any equivalent combination of education and experience that provides the required skill, knowledge, and abilities is qualifying. Typical qualifications would be a baccalaureate degree and a minimum of 3 years of experience collaborating with researchers to assess/improve quality of protocols and supporting components (e.g., recruitment, informed consent, data collection) to ensure compliance with federal human research regulations and sound research principles; experience using electronic IRB submission systems; other experience involving management of regulatory compliance for research involving human subjects. Experience accessing and interpreting multiple resources/references to understand complex regulations. Experience demonstrating analytical thinking and independent problem-solving. Experience interacting with a diverse population.

DESIRED

An advanced degree. Experience in IRB administration of biomedical research. Certified IRB Professional (CIP).

Skills, Knowledge & Abilities (SKA):

• In-depth knowledge of federal/state regulations pertaining to research, ICH GCP, and HIPAA
• In-depth knowledge of clinical research and familiarity with medical terminology
• Effective written and oral communications skills
• Strong problem-solving and independent decision-making skills
• Proficiency with MS Office suite and electronic research/IRB management systems
• Ability to independently prioritize, organize, and efficiently manage multiple ongoing activities
• Ability to work as an effective team member and interact with a diverse population
• Self-motivation to initiate and complete tasks/special assignments
• High standards of professionalism and confidentiality

AA/EOE of Minorities, Women, Veterans and Individuals w/ Disabilities