Hennepin Healthcare Research Institute
Senior IRB Analyst
Hennepin Healthcare Research Institute, Minneapolis, Minnesota, United States, 55400
The Hennepin Healthcare Research Institute (HHRI) is inviting applicants to apply for 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.
DESIREDAn 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
#J-18808-Ljbffr
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.
DESIREDAn 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
#J-18808-Ljbffr