IRB Team Lead

Position Information

University Code 25331 University Title Manager 1, Legal, Audit and Compliance University Job Family Legal, Audit & Compliance ORP Eligible Yes For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Multi Title Scope of Search Regional Working Title IRB Team Lead Position Number 544190 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Office Of Research Organizational Overview

At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.

Position Primary Purpose and General Responsibilities

To facilitate institutional compliance with federal, state and local regulations governing the protection of human research participants.
1. Manage full board administration activities, including comprehensive submission screening, submission tracking, meeting management, membership representation, and oversight of post-meeting activities. Maintain appropriate documentation and reporting of review, study status, and panel activities.
2. Performance management, providing leadership and supervision to IRB administrator team responsible for full board human subjects research submissions to ensure regulatory requirements and timeline goals are met.
3. Conduct substantive pre-review analysis of IRB submissions to ensure adequacy of applications. Conduct IRB review of minor amendments, and participate as an alternate voting member, as needed, ensuring that all regulatory and VCU policy criteria are met. Maintain appropriate documentation and reporting of review and study status.¬¬¬
4. Serve as an educational resource for IRB members, investigators, research personnel, and students. Support the Human Research Protections Program ( HRPP ) by maintaining current knowledge of federal and state regulations, research/medical ethics, IRB Written Policies and Procedures, and HRPP business practices.
This position supports the HRPP in ensuring that departmental objectives related to the review and processing of IRB submissions are met, and will lead and collaborate on efforts to improve compliance with human subjects protection policies and procedures, with a focus on continuous improvement. This includes providing oversight of, or performing, highly complex duties to facilitate the review and approval of human participant research to ensure the rights and welfare of participants are protected and research is conducted in compliance with federal, state, and local regulations, and institutional policies and procedures.

Minimum Hiring Standards

A minimum of 3 years of experience in IRB administration, research compliance, biomedical or social behavioral human participant research, or equivalent. Direct experience in IRB administration is strongly preferred.
Bachelor’s degree in related field strongly preferred, or equivalent combination of training and experience is required.
Advanced working knowledge of complex federal regulations (including FDA ), ethical issues, and institutional policies governing human participant research.
Strong analytical skills necessary to provide a critical analysis of complex research protocols, and independent evaluation of protocol adherence to regulatory criteria and institutional policy.
Ability to independently lead and supervise a team of diverse individuals in an inclusive and motivational way, providing positive and constructive feedback.
Self-directed individual with ability to recognize and analyze potential issues or concerns, and develop potential solutions for resolution.
Demonstrably skilled in professional oral and written communication, with ability to effectively communicate with interdisciplinary internal and external teams.
Exhibits highly effective interpersonal skills to handle sensitive and confidential situations.
Exhibits diplomacy and exceptional customer service skills, with the ability to work with all levels of individuals in a respectful and supportive manner.
Demonstrates strong problem solving and time management skills, including the ability to adapt to frequent changes, and to prioritize and manage competing priorities to meet established time standards.
Demonstrates high level of proficiency in the use of Word and Excel, with ability to accurately type a minimum of 45 words per minute.
Demonstrated experience in organizing and tracking data accurately and appropriately through the use of databases, and the ability to create reports.
Ability to quickly become proficient in the use of an electronic IRB submission and review system ( RAMS - IRB ).
Commitment to expand knowledge of human participant research regulations and ethics.
Demonstrated commitment to continuous program quality improvement, such as identifying areas for increased efficiency or developing solutions to challenges.
Commitment to help ensure a positive, productive, and healthy office environment. Ability to work collaboratively and effectively in a diverse environment is required.
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

Currently holds a Certified IRB Professional ( CIP ) certification, or able to seek certification upon meeting eligibility requirements.
Supervisory or management experience preferred.
Master’s degree preferred.

Required Licenses/ Certifications Anticipated Hiring Range 55,000 - 65,000 Application Process/Additional Information Campus MCV Campus Hours/Week 40 Normal Work Days/Hours Mon-Fri/8-5 Job Open Date 11/11/2020 Posting will close on or before Open Until Filled Yes Job Category Accounting/ Management/ Professional Is this a restricted position? Yes Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position No Resource Critical Yes Quick Link https://www.vcujobs.com/postings/101640 Posting Specific Questions

Required fields are indicated with an asterisk (*).

1. Please describe your knowledge of, and experience with, federal and state regulations pertaining to human subjects research.
   
   (Open Ended Question)
   
   
2. Please describe your experience with Institutional Review Board (IRB) processes, research compliance, and/or the conduct of human subjects research.
   
   (Open Ended Question)
   
   
3. Please describe your experience with critical analysis of research protocols or other complex documents.
   
   (Open Ended Question)
   
   
4. Please describe your experience with project management and leadership, and any supervisory experience.
   
   (Open Ended Question)
   
   

Optional & Required Documents
Required Documents

1. Cover Letter/Letter of Application
2. Resume
3. Curriculum Vitae (CV)

Optional Documents