Senior IRB Analyst

Job Duties

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. Interested candidates should include a cover letter with their application.

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 operations

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

AA/EOE of Minorities/Females/Vets/Disability

Minimum Education Required

Bachelor Degree

Minimum Experience Required

3 - 20 years

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Veterans Encouraged to Apply

No

Physical Required

Yes

Drug Test Required

Yes

Compensation

$11.41 / Hourly

Postal Code

55404

Job Type

Full Time

Place of Work

On-site

Requisition ID

4229757

Job Benefits

Not specified