The Institutional Review Board (IRB) Manager will manage the privileged and confidential institutional review and approval process of all proposed research activities involving human subjects to protect their safety, rights, and welfare. Under administrative direction, the IRB Manager will serve as a member, with vote, on the Institutional Review Board (IRB); perform highly complex duties to facilitate the review and approval process, such as use of independent judgment in interpreting and applying relevant federal and state laws, regulations, and institutional policies and guidelines; conduct literature reviews and prepare reports on scientific topics and on regulatory precedent and changes; instruct IRB chairs, members, and researchers on the regulations and ethical principles essential to the review process; provide training and advice to faculty, staff, and student researchers on the regulations and on preparation of applications and consent forms; and review and approve administrative and procedural modifications of applications. The IRB Manager will be recognized as the lead subject matter expert, and will provide advice and guidance to the IRB staff and board members to facilitate review continuity. They will also help to develop policies and procedures to maintain compliance and increase IRB efficiency. The IRB Manager will manage the IRB administrative staff (comprised of IRB administrators and coordinators) and will report to the Director of Research Compliance.
Primary Duties and Responsibilities:
Serves as a voting member of the IRB, and function as a designated reviewer for exempt and expedited reviews.
Provide advice and guidance in the interpretation of the regulations to increase review continuity among IRB staff and board members.
Interpret and apply federal and state laws, regulations, institutional policies, and guidelines to protect human subjects and to ensure institutional compliance.
Ensures research activities are carried out in a manner that is compliant with all federal, state and local requirements by providing direction on promoting and maintaining required compliance.
Provide regulatory, ethical, and method advice to individual faculty, staff, and students in preparation of applications for research proposals involving human subjects and consent documents.
Draft correspondence that conveys IRB deliberations and contingencies for approval of research activities involving human subjects.
Establish and maintain self as a professional expert and resource to the Organization, patients, families and the Community. Participate in appropriate professional organizations and continuing education programs.
Assist in the development and revision of compliant policies and procedures to aid in IRB efficiency. Assist in program development, implementation, and evaluation.
Directly manage and oversee the IRB administrative staff.
Assist in training and management of inexperienced/junior staff.
Bachelor's degree and at least 5 years’ experience in research administration, with experience directly related to human subjects research and experience performing IRB study protocol reviews. Candidate must have excellent organizational and oral/written communication skills, familiarity with medical terminology, strong interpersonal, problem solving and collaboration skills, ability to interact professionally with MDs and PHDs, ability to maintain professional standards under routine conditions of demanding time constraints, ability to manage staff, and proficient in MS Word, Excel, PowerPoint and Access.