IRB Compliance Administrator

MIT•Cambridge, MA

2d•Hybrid

About The Position

The Institutional Review Board (IRB) Compliance Administrator, within the Office of the Vice President for Research, is responsible for conducting ethical and compliance reviews to ensure adherence to applicable laws and regulations for the use of human subjects in research. This role serves as a point of contact and compliance reviewer for human subject research protocols, identifying regulatory issues and potential risks to participants. The administrator independently reviews and approves studies eligible for expedited review, assists with Committee minutes, communicates with and advises investigators on study modifications, and writes high-level protocol summaries. The position also coordinates ancillary reviews, advises on regulatory landscapes, assists in developing educational materials and conducting workshops, supports COUHES Connect, and maintains knowledge of federal, state, and local regulations. Additional functions will be supported as needed.

Requirements

Bachelor's degree in a related field.
A minimum of three years of human subjects research related experience.
Experience with FDA regulated device research.
Working knowledge of state and federal regulations pertaining to human subject research.
Excellent analytical, organizational, and written and oral communication skills.
Understanding of research procedures’ terminology, clinical trials, and research data management.
Experience conducting and managing human subject research in an academic research environment.
Attention to detail.
Discretion and good judgment with confidential information.
Ability to multitask and prioritize in a fast-paced environment.
Ability to collaborate with faculty, staff, and institutional representatives.
Must obtain CIP certification within one year of meeting the eligibility requirements for the CIP certification exam, if not already Certified IRB Professional (CIP) certified.

Nice To Haves

Three years of experience working at an IRB.
Experience conducting expedited and primary reviews for an IRB.
CIP certification.
Previous experience working at an AAHRPP-Accredited IRB/HRPP.
Experience serving as an IRB board member.
Administrative record keeping experience.
Experience reviewing DOD, NIH, and NSF supported/regulated research.
A background in science and engineering.

Responsibilities

Conduct ethical and compliance reviews to ensure compliance with applicable laws and regulations for the use of human subjects in research.
Serve as a point of contact (POC) and compliance reviewer of human subject research protocols.
Conduct research protocol reviews to identify regulatory and other issues and identify potential risks to research participants.
Independently review and approve studies eligible for expedited review in accordance with the applicable expedited review categories.
Assist with taking Committee minutes.
Correspond with and advise investigators, articulating modifications to study documentation.
Write high-level protocol summaries.
Coordinate ancillary reviews.
Advise colleagues/investigators on navigating the regulatory landscape and applicability of regulations.
Assist with developing educational materials and conduct workshops/presentations.
Assist with COUHES Connect.
Maintain knowledge of federal/state/local regulations.
Support other functions as needed.