The Human Rsrch Protection Analyst coordinates the efficient operation of the Institutional Review Board (IRB). This position is responsible for maintaining the quality assurance standards of the of the IRB operation. Additionally, this role will provide leadership to less experienced specialists assigned, and to provide regulatory guidance to the IRB that ensures compliance with all federal and regulatory requirements and accreditation standards.
Work to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations.
Ensures ability to measure metrics for accreditation and analyze metrics to ensure the efficient operation of all research committees.
Coordinates the activities of the Network Research Compliance Committee and follows up on issues related to the human research protection with the guidance and support of the Dir, Human Research Protection Program.
Maintains 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.
As a voting member, conducts review of submissions to the IRB.
Provides feedback to the Mgr, Research Integrity regarding team performance, need for personnel, policy and procedural recommended changes and other IRB issues.
Maintain a strong lead role in the direction of IRB operating procedures by making recommendations for process improvement purposes.
Works closely with the IRB Chair(s) to provide guidance in the review and processing of submissions.
Ensures that all correspondence related to the respective IRB is accurate prior to finalization.
Serves on committees constituted to improve the functioning of the IRB office.
Advises investigators as to the content of submission to facilitate efficient review.
Serves as voting member of IRB which requires a strong understanding of research and federal regulations as this position will be responsible for expedited review of studies.
Other projects as assigned by the Manager or Director.
Bachelor's degree in biomedical sciences, ethics, public health or related field.
Minimum 5 years of IRB experience and knowledge of OHRP and FDA regulations.
Demonstrated written and oral communications skills.
Ability to perform multiple tasks with a high level of accuracy and attention to detail.
Working knowledge of research and medical terminology.
Demonstrated ability to work independently in a team-oriented environment, follow through, independently perform against deadlines with frequent interruptions and competing priorities.
Ability to exercise sound judgment and initiative in collecting technical information from a wide variety of sources; to maintain confidentiality with tact and discretion; to interpret and apply ethical principles.
Strong computer skills including MS Office, Word, Excel.
Overall understanding of institutional entities, policies, and relationships that affect IRB functioning.