Sr IRB Generalist (REMOTE)
About the position Responsibilities • 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. Requirements • 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. Nice-to-haves • Master's degree in a related field. • Certified IRB Professional (CIP). • Minimum of 5 years experience as an IRB or reliance analyst. Benefits • Health insurance • Dental insurance • Vision insurance • 401k retirement plan • Paid holidays • Flexible scheduling • Professional development opportunities Apply tot his job Apply tot his job