Single IRB Specialist

Responsible for reviewing and approving applications for participating sites that are relying on IRB oversight. This position ensures that all site-specific institutional requirements have been met prior to approval/activation of the research at each participating site. Also responsible for reviewing requests from research to rely on the review to external IRBs. This position involves regular interaction with others within the system, including offices and ancillary committees involved in the Human Research Protection Program.

Reports to Assistant Director, sIRB Program.

• Acts as the primary liaison for investigators relying on external sIRBs and investigators at sites relying on the IRB for sIRB oversight in multi-site research.
• Conducts reviews of applications for relying sites overseen by the sIRB in compliance with all applicable federal, state and local regulations as well as institutional policies and procedures, and guidelines.
• Determines the eligibility to rely on external reviewing sIRBs based on institutional policies and standard operating procedures.
• Coordinates the review and negotiation of individual study reliance agreements with external sIRBs when needed; prepares individual investigator agreements for investigators who are employees/agents of institutions.
• Communicates policies and requirements to external sIRBs as applicable; reviews model consent form(s) for compliance with consent form requirements (such as payment for injury, HIPAA).
• Participates in the development and implementation of educational workshops and activities for the research community.
• Works with the Assistant Director and others to identify and resolve problems and formulate short- and long-term goals and objectives.
• Interacts, as needed, with federal and state regulatory agencies.

• Bachelor's Degree required (experience can be substituted in place of a degree)
• Master's Degree preferred

• IRB professional (CIP) within 2 years of hire 1-2 years preferred

• At least 5-7 years of experience in clinical research or regulatory affairs required

• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently and as a team member.
• Working knowledge of clinical research protocols.
• Analytical skills and ability to resolve problems.
• Strong understanding of federal regulations, such as the Common Rule, HIPAA, and other relevant research compliance standards.
• High degree of computer literacy.

• This is a full-time remote role that can be done from most US states
• The Monday through Friday schedule is five 8-hour days with a preference for a start time no later than 8:30 AM EDT on weekdays

Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.