IRB Generalist
Virginia Commonwealth University
Richmond, VA
Full-time
Human Resources
Posted on April 24, 2024
Welcome to Virginia Commonwealth University (VCU) … a world unlike any other!
At VCU we combine learning, research, creativity, service and discovery with a commitment to inclusive excellence. Ranked by U.S. News as one of the 30 “most innovative” public universities in the country, VCU is a premier, urban, public research university home to multiple nationally ranked programs.
VCU's Office of the Vice President for Research and Innovation's (OVPRI) mission is to foster transformative research, discovery and innovation at Virginia Commonwealth University through excellence in service.
Through our passion for discovery and willingness to take on challenges, we continue to advance the work that matters most and position the university as a national leader in research, innovation, creativity and scholarship. Our commitment has resulted in record levels of sponsored research and has placed VCU among the nation's premier public research universities. OVPRI link https://research.vcu.edu/
The OVPRI and the Human Research Protection Program (HRPP) invites all interested candidates to apply for an exciting opportunity as the IRB Operational Manager (Job Family - Legal, Audit & Compliance, Job Title - Administrator LG 1, Job Code - 25911).
Summary of Position Primary Purpose and General Duties:
The role of the IRB Generalist at Virginia Commonwealth University is instrumental in facilitating the review and implementation of reliance agreements, individual investigator agreements, and ceding memos. Proficiency in utilizing platforms such as Smart IRB and IRex is essential to streamline the reliance process while ensuring adherence to institutional policies and federal regulations governing human participant research. Efficient collaboration between research institutions is fostered through this role.
Key responsibilities include conducting comprehensive pre-review and post-review analyses of IRB submissions, identifying and addressing missing information, and coordinating with investigators to rectify any deficiencies. The Generalist also verifies ancillary committee reviews and, upon compliance confirmation, facilitates external IRB review.
Additionally, meticulous record-keeping of IRB reliance relationships and approved studies by external IRBs is essential, including retention of approval letters and reportable events. Serving as a liaison between external IRBs, the Office of Research and Sponsored Programs, and VCU study teams ensures timely and compliant reviews. Collaboration with colleagues in managing the IRB Reliance Program and providing guidance to researchers is integral to this role.
Key Responsibilities:
Reliance Agreement Review:
Thoroughly review reliance agreements, individual investigator agreements, and ceding memos to ensure alignment with institutional policies and regulatory requirements.
Collaborate with research teams to address discrepancies or missing information in agreements.
Smart IRB and IRex Management:
Utilize Smart IRB and IRex platforms to streamline the reliance process.
Update information within these systems to maintain accurate records and facilitate communication between collaborating institutions.
Compliance Assurance:
Verify that all agreements comply with institutional policies and procedures.
Ensure compliance with federal regulations governing human participant research.
Communication and Collaboration:
Act as a liaison between the IRB, research teams, and external institutions involved in reliance agreements.
Facilitate effective communication and coordination throughout the reliance process.
Conduct administrative local reviews for external IRB submissions per the standard operating procedures.
Conduct Single Reviewer and Administrative Reviews:
Conducting Single Reviewer and Administrative Reviews for the IRB involves several key tasks essential for the efficient processing and oversight of research protocols. Here's an expanded overview:
Initial Protocol Screening:
Review incoming research protocols to determine if they qualify for single reviewer or administrative review.
Evaluate the complexity and risk level of each protocol to determine the appropriate review pathway.
Single Reviewer Review:
Conduct a comprehensive review of research protocols assigned for single-reviewer review.
Assess protocol documents, including study protocols, consent forms, and recruitment materials, to ensure compliance with institutional policies and regulatory requirements.
Evaluate the scientific merit, ethical considerations, and feasibility of the proposed research.
Administrative Review:
Perform administrative reviews for research protocols eligible for expedited review or administrative processing.
Verify that protocols meet the criteria for expedited review, including minimal risk, involvement of vulnerable populations, and use of established procedures.
Ensure completeness and accuracy of protocol submissions, including required documentation and consent forms.
Communication and Coordination:
Communicate with investigators regarding any necessary revisions or clarifications to protocol documents.
Coordinate with IRB staff and committee members to address any questions or concerns arising during the review process.
Provide guidance and support to investigators to facilitate the review process and ensure timely approval of protocols.
Regulatory Compliance:
Ensure compliance with federal regulations, state laws, and institutional policies governing human research protection.
Verify that protocols adhere to ethical standards, including protection of participant rights, confidentiality, and informed consent.
Address any regulatory or compliance issues identified during the review process, working collaboratively with investigators to resolve concerns.
Documentation and Record Keeping:
Maintain meticulous records of reliance agreements, individual investigator agreements, and ceding memos.
Ensure completeness and accuracy of documentation for auditing purposes.
Continuous Improvement:
Identify opportunities for process improvement in reliance agreement execution.
Collaborate with stakeholders to implement enhancements and optimize efficiency.
Minimum Hiring Standards:
Bachelor's degree in a related field or equivalent training and experience may include work in an IRB office or conducting research studies with proven coordination and information processing abilities.
Minimum of 2 years experience working as an IRB analyst.
Eligibility and willingness to seek certification as a Certified IRB Professional (CIP).
The candidate should have demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
Preferred Hiring Standards:
Master's degree in a related field or equivalent training and experience may include work in an IRB office or conducting research studies with proven coordination and information processing abilities.
Minimum of 5 years' experience working as an IRB or reliance analyst.
Certified as a Certified IRB Professional (CIP).
Experience in human participant research and familiarity with institutional policies and procedures regarding human participant research.
Additional Employment Information
All full-time university staff are eligible for our generous benefits package that includes choices for health, vision and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off, 12 paid holidays and more.
Explore our robust benefit package here: https://hr.vcu.edu/current-employees/benefits/
In a world of the common, we are the UNCOMMON and UNSTOPPABLE. It's innovation at work. VCU is nationally recognized as one of the best employers for diversity, a place of opportunity where your success is supported and your career can thrive, and more than 300,000 strong.
Salary Range: Commensurate with experience
Position Details:
Department: Office of the Vice President for Research & Innovation - Human Research Protection
Program
Position Information: Job Family - Legal, Audit & Compliance, Job Title - Analyst LG, Job Code (25221)
ORP Eligible: No
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 1.0
Exemption Status: Exempt
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