Human Research Compliance Specialist

2 months ago

Richmond, Virginia, United States Commonwealth of Virginia Full time
Welcome to the Commonwealth of Virginia - a hub of innovation and excellence

At the Commonwealth of Virginia, we merge education, research, creativity, and community service with a commitment to inclusivity and excellence. Recognized nationally for our innovative approach, we stand out as a leading public research institution with multiple esteemed programs.

Join our Office of Research and Innovation, where our mission is to foster transformative research, discovery, and innovation through exceptional service. Our dedication to advancing significant work positions us as a prominent center for research, creativity, and scholarship.

Our commitment has resulted in unprecedented levels of sponsored research, establishing us as one of the foremost public research institutions in the nation.

We are seeking a Human Research Compliance Specialist

Job Overview and General Responsibilities:

The Human Research Compliance Specialist plays a crucial role by facilitating the review and execution of reliance agreements, individual investigator agreements, and ceding memos. Proficiency in platforms such as Smart IRB and IRex is vital for optimizing the reliance process and ensuring adherence to institutional policies and federal regulations governing human participant research. Effective collaboration with research institutions is a fundamental aspect of this position.

  • Conduct thorough pre-review and post-review evaluations of research submissions
  • Identify and rectify missing information, coordinating with investigators for resolution
  • Verify ancillary committee reviews and facilitate external IRB assessments
  • Maintain detailed records of IRB reliance relationships and approved studies by external IRBs
  • Act as a liaison between external IRBs, the Office of Research and Sponsored Programs, and research teams
  • Provide guidance to researchers and oversee the IRB Reliance Program
Key Duties:
  • Review of Reliance Agreements: Ensure compliance with institutional policies and regulatory standards
  • Management of Smart IRB and IRex: Utilize these platforms for efficient reliance processes
  • Compliance Verification: Confirm adherence to policies and federal regulations
  • Facilitation of Communication: Serve as a liaison among stakeholders to promote effective dialogue
  • Conducting Reviews: Perform Single Reviewer and Administrative Reviews for efficient oversight of research protocols
Expanded Responsibilities:
  • Initial Protocol Evaluation: Assess research protocols to determine the appropriate review pathway
  • Single Reviewer Assessment: Evaluate protocol documents for compliance and feasibility
  • Administrative Review: Ensure completeness and accuracy of protocol submissions
  • Coordination and Communication: Collaborate with investigators and IRB staff throughout the review process
  • Regulatory Adherence: Ensure compliance with federal regulations and ethical standards
  • Documentation and Record Maintenance: Keep precise records for auditing purposes
  • Continuous Process Improvement: Identify and implement enhancements to existing processes
Minimum Qualifications:

A Bachelor's degree in a relevant field, two years of experience as an IRB analyst, and eligibility for Certified IRB Professional (CIP) certification.

Preferred Qualifications:

A Master's degree in a related field, five years of experience as an IRB analyst, Certified IRB Professional (CIP), and expertise in human participant research.

Additional Employment Information

Full-time staff enjoy a comprehensive benefits package, including health, vision, dental coverage, life insurance, retirement planning, paid time off, and more.

Join us at the Commonwealth of Virginia, where we drive innovation and success in a diverse and supportive environment.

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