Senior IRB Analyst

The Hennepin Healthcare Research Institute (HHRI) has an immediate opening for an experienced Institutional Review Board (IRB) Analyst to complete the multi-disciplinary team that supports the research being conducted at Hennepin Healthcare.

This is a hybrid role that requires a periodic onsite presence on the HCMC campus located in downtown Minneapolis, MN.

POSITION SUMMARY:

The IRB Analyst supports 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. This position requires understanding, analysis, and application of institutional SOPs and international, federal, state, and local rules and regulations and ethical principles pertaining to human subjects in research.

ESSENTIAL JOB FUNCTIONS:

HRPO operations

- Follow HRPO workflows and operations

- Provide backup for HRPO staff responsibilities as needed

- Support IRB members, as needed

- Serve as a resource on general regulatory information regarding human research and navigations of the electronic IRB submission system

- Serve as a resource regarding ancillary processes related to IRB oversight

IRB o perations

Manage processes in Cayuse HE to process IRB submissions, including the following:

- Support timely processing, review, and disposition of assigned submissions

- Provide support/instruction to researchers regarding preparation/process of submissions

- Perform screening/review of submissions including new studies, modifications, reportable new information, continuing review reports, and closure requests to ensure completeness and conformance with HRPO SOPs.

- Ensure timely processing and follow-up communication with researchers

IRB meetings

- 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

- 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 knowledge and skills is qualifying. Typical qualifications would be a baccalaureate degree and a minimum of 3 years of experience in IRB administration, clinical research, or other related job demonstrating direct relevance to regulatory compliance and research with human subjects.

Desired:

Direct experience in IRB administration of biomedical research. Certified IRB Professional (CIP).

Skills, Knowledge & Abilities (SKA)

- Basic knowledge of federal/state regulations pertaining to research, ICH GCP, and HIPAA

- Basic knowledge of clinical research and familiarity with medical terminology

- Effective written and oral communications skills

- Strong problem-solving and decision-making skills

- Ability to independently prioritize, organize, and efficiently manage multiple ongoing activities

- Must be mature, self-motivated, and responsible; must be able to initiate and complete routine and non-routine tasks

- Ability to work as an effective team member

- Proficiency with MS Office suite

- Experience with electronic research/IRB management systems

- Displays high standards of punctuality, attendance, maintains confidentiality, and manages time effectively

- Requires interaction with a diverse population

Hennepin Healthcare Research Institute is an Equal Opportunity Employer