IRB Operational Manager - Virginia Commonwealth University

Welcometo Virginia Commonwealth University (VCU) … a world unlike any other!

At VCU we combine learning,research, creativity, service and discovery with a commitment to inclusiveexcellence. Ranked by U.S. News as one of the 30 “most innovative” publicuniversities in the country, VCU is a premier, urban, public researchuniversity 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 atVirginia Commonwealth University through excellence in service. 

Through our passion for discovery and willingness to take on challenges, we continueto advance the work that matters most and position the university as a nationalleader in research, innovation, creativity and scholarship.  Ourcommitment has resulted in record levels of sponsored research and has placedVCU among the nation’s premier public research universities.  OVPRI linkhttps://research.vcu.edu/

The OVPRI and the Human Research Protection Program (HRPP) invites allinterested candidates to apply for an exciting opportunity as the IRB Operational Manager  (Job Family - Legal, Audit & Compliance, Job Title - AdministratorLG 1, Job Code - 25911).

Summary of Position Primary Purposeand 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.     

AdditionalEmployment Information

All full-time university staff are eligible for our generous benefits package thatincludes choices for health, vision and dental coverage, life-insurance, shortand long-term disability coverage, retirement planning, tax-deferred annuityand 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 bestemployers for diversity, a place of opportunity where your success is supportedand 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