Sr IRB Generalist (REMOTE)

Virginia Commonwealth University-posted about 1 year ago
$85,000 - $90,000/Yr
Full-time • Mid Level
Remote • Richmond, VA
Educational Services
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

The Senior IRB Generalist at Virginia Commonwealth University plays a crucial role in managing the review and implementation of research protocols, ensuring compliance with institutional policies and federal regulations. This position requires proficiency in platforms like Smart IRB and IRex to facilitate the reliance process and promote collaboration between research institutions. The Senior IRB Generalist will oversee a substantial portfolio of research protocols, provide regulatory support, and ensure adherence to accreditation standards while working closely with the IRB Operations Manager and other professionals in the IRB operation.

  • Manage a large volume of research protocols and related submissions, ensuring quality and uniformity of review.
  • Ensure compliance of research protocols with VCU IRB standard operating procedures and applicable regulations.
  • Lead the IRB team to meet quality and productivity expectations, providing feedback and encouragement.
  • Conduct independent analysis of protocols and document findings for Principal Investigators.
  • Evaluate PI responses and advise on regulatory items for IRB approval.
  • Participate in the evaluation of IRB Chairs and members.
  • Guide IRB Chairs and reviewers on regulatory requirements and provide necessary information.
  • Train new IRB members on the VCU electronic review system and facilitate onboarding.
  • Provide administrative and regulatory support to the IRB Chair in processing submissions.
  • Conduct quality control functions for HRPP operations, reviewing files and meeting minutes for accuracy.
  • Serve as a resource for the VCU research community and HRPP staff.
  • Serve as a voting member of the IRB and other VCU IRBs as needed.
  • Assign events to primary reviewers as designated by the IRB Chair.
  • Maintain and develop knowledge of federal and state regulations governing human subject research.
  • Notify management of necessary updates to guidance and policies, identifying gaps and assisting with revisions.
  • Serve as an SRC expedited reviewer for certain protocol submissions.
  • Assist HRPP Leadership in identifying areas for enhancement and recommending solutions.
  • Prepare pre-review comments of protocol submissions and informed consent documents.
  • Train and guide HRPP staff on consent forms and research documents.
  • Independently manage special projects and lead internal HRPP committees or workgroups.
  • Conduct training sessions within the research community.
  • Bachelor's Degree or equivalent in education and experience.
  • 5 years of experience in the research field or research oversight, with at least 3 years of direct IRB experience.
  • Familiarity with the Huron HRPP toolkit.
  • Up-to-date knowledge of state and federal regulations related to human subjects research.
  • Strong organizational and time management skills to handle a large volume of submissions.
  • Strong decision-making skills and analytical abilities to assess complex research protocols.
  • Self-motivated with the ability to function independently in a high-intensity environment.
  • Excellent interpersonal and written communication skills.
  • Ability to work collaboratively in a positive manner.
  • Solid computer skills and competency in Microsoft Office products.
  • Master's degree in a related field.
  • Certified IRB Professional (CIP).
  • Minimum of 5 years experience as an IRB or reliance analyst.
  • Health insurance
  • Dental insurance
  • Vision insurance
  • 401k retirement plan
  • Paid holidays
  • Flexible scheduling
  • Professional development opportunities
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service