IRB Analyst
University of Minnesota-Twin Cities
Twin Cities, MN
ID: 7262365
Posted: July 12, 2024
Application Deadline: Open Until Filled
Job Description
Core Position Duties and Responsibilities
Support of Daily IRB Operations (50%)
Adhere to and accurately apply the UMN HRPP Toolkit, which includes local and federal regulations, guidelines, and ethical principles.
Process scientific assessment submissions, including routing to scientific reviewers and ensuring timely completion, communicating review feedback to investigators, and returning any follow-up communications or revisions as appropriate.
Process submissions such as New Studies, Modifications, Continuing Review, and Reports of New Information.
Conduct pre-review to ensure submissions are review-ready.
Process and review reliance/sIRB related submissions.
Provide initial feedback to investigators regarding submission completeness and compliance.
Route submissions for either non-committee or committee review and track expedited reviews.
Communicate review results to investigators and compose detailed correspondence to ensure committee concerns and rationale are clear.
Evaluate investigator’s responses to identify potential issues for research reviewers.
Escalate concerns to the IRB Assistant Director and/or Senior Analyst as appropriate.
IRB Panel Coordination and Regulatory Support (20%)
Perform duties as specified in the UMN HRPP Toolkit while meeting efficiency goals set by department
Set agendas and prepare submissions for review by the convened IRB.
Assign reviewers to submissions and manage IRB meeting agendas.
Confirm IRB member attendance to ensure quorum and monitor quorum during meetings.
Document IRB determinations made by the convened IRB
Generate meeting minutes and correspondence.
Review submissions to anticipate regulatory issues for IRB members (e.g., IND/IDE questions).
Designated Review Responsibilities (15%)
Conduct non-committee reviews for certain submissions.
Route submissions appropriately when unable to conduct non-committee reviews due to time constraints or subject matter knowledge.
IRB Support for Research Community (10%)
Provide customer service that meets the mission and facilitates understanding of compliance requirements.
Communicate and consult with investigators and their designees related to human research protocol matters.
Other Duties as Assigned (5%)
Assist with additional tasks as directed by IRB leadership.
⇒ Additional Responsibilities for IRB Analyst II ⇐
Independently process submissions with minimal supervision.
Interpret and apply regulations to complex submissions and seek expert consultation as needed.
Provide support during ETHOS upgrades and user acceptance testing.
Serve as a resource to IRB Analyst I to facilitate ongoing training and quality improvement.
Mentor IRB Analyst I during IRB meetings and in performing daily duties.
Provide expert regulatory guidance to IRB Chair and members.
Participate in education and training activities as requested by department leadership.
The Research and Innovation Office (RIO) and HRPP endorses a “work with flexibility” approach that offers a welcoming and flexible work environment where everyone is inspired to do their best. Work location options include working fully remote, partially remote, or entirely in the office and are based on the work of the position. Some on-site work may be necessary for certain positions, even those designated as fully remote.
This position has been designated as eligible for flexible work profile four.
Profile four is expected to work fully remotely with the exception of required attendance for on-site events. Your dedicated work space will be in your remote work location. HRPP management retains the right to modify flexible work arrangement agreements on a temporary or permanent basis for any reason at any time.
Salary Information
The anticipated salary range for an IRB Analyst I is $54,000-$56,000, based on education and work experience.
The anticipated salary range for an IRB Analyst II is $59,000-$63,000, based on education and work experience.
Qualifications
IRB Analyst 1
Required Qualifications
BA/BS degree with at least two years of experience, or a combination of related education and work experience to equal six years.
Preferred Qualifications
Certified IRB Professional (CIP)
IRB Analyst II
Required Qualifications
BA/BS degree with at least two years of direct IRB experience, or a combination of related education and work experience to equal six years. Demonstrated ability to take on additional responsibilities both independently and accurately.
Preferred Qualifications
CIP certification or 15 years of relevant IRB experience.
Support of Daily IRB Operations (50%)
Adhere to and accurately apply the UMN HRPP Toolkit, which includes local and federal regulations, guidelines, and ethical principles.
Process scientific assessment submissions, including routing to scientific reviewers and ensuring timely completion, communicating review feedback to investigators, and returning any follow-up communications or revisions as appropriate.
Process submissions such as New Studies, Modifications, Continuing Review, and Reports of New Information.
Conduct pre-review to ensure submissions are review-ready.
Process and review reliance/sIRB related submissions.
Provide initial feedback to investigators regarding submission completeness and compliance.
Route submissions for either non-committee or committee review and track expedited reviews.
Communicate review results to investigators and compose detailed correspondence to ensure committee concerns and rationale are clear.
Evaluate investigator’s responses to identify potential issues for research reviewers.
Escalate concerns to the IRB Assistant Director and/or Senior Analyst as appropriate.
IRB Panel Coordination and Regulatory Support (20%)
Perform duties as specified in the UMN HRPP Toolkit while meeting efficiency goals set by department
Set agendas and prepare submissions for review by the convened IRB.
Assign reviewers to submissions and manage IRB meeting agendas.
Confirm IRB member attendance to ensure quorum and monitor quorum during meetings.
Document IRB determinations made by the convened IRB
Generate meeting minutes and correspondence.
Review submissions to anticipate regulatory issues for IRB members (e.g., IND/IDE questions).
Designated Review Responsibilities (15%)
Conduct non-committee reviews for certain submissions.
Route submissions appropriately when unable to conduct non-committee reviews due to time constraints or subject matter knowledge.
IRB Support for Research Community (10%)
Provide customer service that meets the mission and facilitates understanding of compliance requirements.
Communicate and consult with investigators and their designees related to human research protocol matters.
Other Duties as Assigned (5%)
Assist with additional tasks as directed by IRB leadership.
⇒ Additional Responsibilities for IRB Analyst II ⇐
Independently process submissions with minimal supervision.
Interpret and apply regulations to complex submissions and seek expert consultation as needed.
Provide support during ETHOS upgrades and user acceptance testing.
Serve as a resource to IRB Analyst I to facilitate ongoing training and quality improvement.
Mentor IRB Analyst I during IRB meetings and in performing daily duties.
Provide expert regulatory guidance to IRB Chair and members.
Participate in education and training activities as requested by department leadership.
The Research and Innovation Office (RIO) and HRPP endorses a “work with flexibility” approach that offers a welcoming and flexible work environment where everyone is inspired to do their best. Work location options include working fully remote, partially remote, or entirely in the office and are based on the work of the position. Some on-site work may be necessary for certain positions, even those designated as fully remote.
This position has been designated as eligible for flexible work profile four.
Profile four is expected to work fully remotely with the exception of required attendance for on-site events. Your dedicated work space will be in your remote work location. HRPP management retains the right to modify flexible work arrangement agreements on a temporary or permanent basis for any reason at any time.
Salary Information
The anticipated salary range for an IRB Analyst I is $54,000-$56,000, based on education and work experience.
The anticipated salary range for an IRB Analyst II is $59,000-$63,000, based on education and work experience.
Qualifications
IRB Analyst 1
Required Qualifications
BA/BS degree with at least two years of experience, or a combination of related education and work experience to equal six years.
Preferred Qualifications
Certified IRB Professional (CIP)
IRB Analyst II
Required Qualifications
BA/BS degree with at least two years of direct IRB experience, or a combination of related education and work experience to equal six years. Demonstrated ability to take on additional responsibilities both independently and accurately.
Preferred Qualifications
CIP certification or 15 years of relevant IRB experience.