IRB Operational Manager
Virginia Commonwealth University
Richmond, VA
Full-time
Administration / Clerical
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 IRB Operational Manager is responsible for overseeing the daily operations of the Institutional Review Board (IRB), ensuring compliance with regulatory requirements and efficient processing of all types of research protocols. This role involves managing the full board, expedited, exempt, Non-Human Subject Research (NHSR), and reliance divisions within the IRB.
Manage and coordinate the daily activities of operations staff
Within the scope of this position, this position is responsible for the day-to-day leadership of a team, ensuring that quality and turn-around time (TAT) expectations are met while contributing to the company's overall mission to protect the rights and welfare of human subjects involved in research.
Maintain and promote positive working relationships with clients by providing timely and professional service to their needs within the scope of the company mission and accompanying regulations
Supervise the work (including priorities and distribution of workload) of Operations staff
Deal effectively with high volumes, deadlines and frequent changes; Review individual as well as group queues daily in order to prevent client delays
Responsible for assigning work to staff; organize and prioritize workflow to meet deadlines and maximize efficiency of the team
Oversee and assist when necessary, in the review of new study applications as well as change in review submissions and ensure they are complete and accurate according to internal standards
Be familiar with expectations of submission requirements
Be a point of Contact for clients for inquiries and resolution of complaints
Communicate with clients regarding services offered and timelines
Communicate information and implement new processes and procedures
Work as a team with all operational personnel creating and implementing improved processes and policies
Perform quality checks of final information and documents produced by the department
Establish and maintain industry contacts and sources that identify and lead to the successful development of new business and expansion of current business
Stay abreast of applicable federal regulations governing IRB review of research by attending seminars, training sessions, professional meetings, and maintaining certifications
Other duties as assigned by supervisor
Key Responsibilities:
Full Board Support: Oversee the daily coordination and facilitation of meetings of the full board, including scheduling, agenda preparation, and documentation. Ensure thorough review of protocols, compliance with regulations, and timely decision-making.
Expedited Review Oversight: Supervise the expedited review process, including the assignment of protocols to reviewers, monitoring timelines, and ensuring appropriate documentation of reviews.
Exempt Determinations: Supervise the exempt review process, including the evaluation of research protocols for exemption criteria, documentation of determinations, and communication with researchers.
Non-Human Subject Research (NHSR) Determination: Supervise the review and approval process for research involving non-human subjects, such as tissue samples or data analysis. Ensure compliance with relevant regulations and institutional policies.
Reliance Agreements Coordination: Supervise the facilitation of the establishment and management of reliance agreements with external institutions or entities, including negotiation, documentation, and ongoing communication to ensure compliance with regulatory requirements.
Minimum Hiring Standards:
Bachelor's degree in a related field (e.g., healthcare administration, public health, or life sciences).
Minimum of 3 years experience working as an IRB Operational Manager or equivalent.
Certified as a Certified IRB Professional (CIP).
Comprehensive understanding of relevant regulations and guidelines governing human subjects research (e.g., Common Rule, FDA regulations, HIPAA).
Strong organizational skills with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with researchers, IRB members, and external stakeholders.
Proficiency in Microsoft Office Suite and electronic research administration systems.
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 Operational Manager.
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 - Administrator LG, Job
Code (25911)
ORP Eligible: Yes
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 1.0
Exemption Status: Exempt
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