Irb Operational Manager

2 weeks ago

Richmond, United States Virginia Commonwealth University Full time

**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.
- **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**
- 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
- 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.
- 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).
- 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.
- **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.
- In a world of the

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