What are the responsibilities and job description for the Senior IRB Analyst position at Hennepin Healthcare Research Institute?
### 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
Education/Experience
EMPLOYMENT STANDARDS:
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
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
Education/Experience
EMPLOYMENT STANDARDS:
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
Salary : $11