Sr. IRB Generalist (REMOTE)

Sr. IRB Generalist (REMOTE)

Benefits of working at VCU

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Job Code 25224
Recruitment Pool All Applicants
Posting Number req6139
Unit VP Research MBU
Department Vice President for Research and Innovation
Department Website Link https://research.vcu.edu/
Location VCU
Address 907 Floyd Ave, Richmond, VA 23284 USA
Duties & Responsibilities

Summary:



The role of the Senior 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.

The Senior IRB Generalist is responsible for the management of a substantial portfolio of research protocols submitted for IRB review, facilitating regulatory support to a VCU IRB, and ensuring the respective IRB is in compliance with all federal regulatory and local requirements and accreditation standards. This staff member will join other professionals who are responsible for the management of the IRB operation. The Senior IRB Generalist reports to the IRB Operations Manager.

Core Responsibilities:

• Manage a large volume of research protocols and related submissions, from assignment through IRB approval, and ensure a high level of quality and uniformity of review of these protocols
  
  
• Ensure research protocols submitted for IRB review are in compliance with VCU IRB standard operating procedures (SOPs) and institutional policies as well as applicable federal and state regulations
  
  
• Lead the designated IRB team to meet HRPP’s expectation for quality, productivity, and goal accomplishment; encourage IRB generalist contribution and provide feedback
  
  
• Provide a detailed independent analysis of protocols-specific events submitted for IRB, document submission-specific findings, and generate Principal Investigator (PI) notification regarding the outcome of the review
  
  
• Evaluate PI responses and identify regulatory items for IRB reviewers; advise as to whether or not the requirements for IRB approval have been met
  
  
• Participate in the evaluation of the IRB Chairs and members
  
  
• Guide IRB Chairs and IRB reviewers with the application of regulatory requirements and provide them with the necessary information to conduct their reviews
  
  
• Train new IRB members on how to use the VCU electronic review system (Smart IRB and IRex) and facilitate onboarding
  
  
• Work closely with the IRB Chair to provide administrative and regulatory support in the review and processing of submissions
  
  
• Conduct quality control functions for the HRPP that may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy, and consistency
  
  

• Serve as a resource for the VCU research community and other HRPP staff
  
  
• Serve as a voting member of the IRB they support and other VCU IRBs as needed
  
  
• As applicable, assign events to the primary reviewer(s) as designated by the IRB Chair
  
  
• Maintain and further develop knowledge about the federal and state regulations governing human subject research and related institutional policies and procedures; continuously interpret and apply these requirements to human subject research protocols and ongoing research activities
  
  
• Notify the manager and respective Director when guidance and/or policies require updating; Include identification of policy/guidance gaps and assistance with policy and guidance revision
  
  
• Serve as an SRC expedited reviewer with the ability to approve certain types of protocol submissions eligible for expedited SRC review
  
  
• Assist HRPP Leadership in identifying areas for enhancement to increase efficiency and compliance, as well as recommending proposed solutions
  
  
• Independently prepare pre-review comments of protocol submissions and informed consent documents in anticipation of SRC reviews
  
  
• Train, educate, and guide HRPP staff on reviewing and revising consent forms and other documents integral to the conduct of research involving human subjects
  
  
• Independently manage special projects as assigned
  
  
• Actively lead an internal HRPP committee and/or workgroup
  
  
• Independently conduct training sessions within the research community either to groups or in one-on-one sessions
  
  

Duties common to all Senior IRB Generalists:

• Serve on committees constituted to improve the functioning of the IRB office
  
  
• Process reliance reviews within Smart IRB and IRex updates
  
  
• Maintain awareness of institutional entities, policies, and relationships that affect IRB functioning
  
  
• Develop positive relationships with researchers and colleagues throughout VCU to facilitate greater efficiency of HRPP processes
  
  
• Work with other HRPP officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations
  
  
• Maintain up-to-date knowledge of state and federal regulations as well as policies, guidelines, and ethical codes related to the protection of human subjects in research
  
  

Qualifications

Minimum Qualifications

• Bachelor's Degree or equivalent in education and experience
  
  
• 5 years of experience working in the research field or research oversight; At least 3 years must be of direct IRB experience
  
  
• Must be familiar with the Huron HRPP toolkit
  
  
• The Senior IRB Generalist must have up-to-date knowledge of state and federal regulations and be familiar with policies, guidelines, and ethical codes related to the protection of human subjects in research
  
  
• Strong organizational and time management skills to support a large volume of submissions, review deadlines, and researcher (PI) expectations while maintaining a high degree of accuracy and attention to detail
  
  
• Strong decision-making skills and demonstrated ability to assess multiple issues analytically to apply knowledge of federal regulations and institutional policy to a variety of complex situations and research protocols
  
  
• Self-motivated to function independently in a high-intensity environment often driven by deadlines
  
  
• Know when to refer issues to the Supervisor and have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision
  
  
• Excellent interpersonal and written communication skills
  
  
• Ability to work collaboratively in a positive and effective manner
  
  
• Solid computer skills and strong competency in Microsoft Office products; familiarity with computerized databases preferred
  
  

Preferred Qualifications

• Master’s degree in a related field
  
  
• Certified IRB Professional (CIP)
  
  
• Minimum of 5 years experience working as an IRB or reliance analyst
  
  

FLSA University Employee
Job FTE 1
Exemption Status Exempt
Restricted Position Yes
E-Class UF - University Employee FT
Job Category University Employee
ORP Eligible No
Salary Range $85,000-$90,000
Compensation Type Salaried
Target Hire Date 11/29/2024
Contact Information for Candidates

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