INSTITUTIONAL REVIEW BOARD (IRB) COMPLIANCE ADMINISTRATOR, Office of the Vice President for Research,to conduct ethical and compliance reviews to ensure compliance with applicable laws and regulations for the use of human subjects in research. Will 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; correspond with and advise investigators, articulating modifications to study documentation; write high-level protocol summaries, coordinate ancillary reviews, and advise colleagues/investigators on navigating the regulatory landscape and applicability of regulations; manage and evaluate single IRB reliance requests and serve as POC for SMART IRB; direct communications between relying and reviewing institutions and carry out reliance actions; serve as a clinicaltrials.gov registration representative; assist with developing educational materials and conduct workshops/presentations; assist with COUHES Connect; maintain knowledge of federal/state/local regulations; and support other functions as needed.
Job Requirements REQUIRED: B.S./B.A. in related field; at least three years’ human subjects research related experience; 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; and ability to multitask and prioritize in a fast-paced environment and collaborate with faculty, staff, and institutional representatives.
PREFERRED: three years’ experience working at an IRB; experience conducting expedited and primary reviews for an IRB; CIP certification; experience reviewing DOD, FDA, NIH, and NSF supported/regulated research; and a background in science and engineering. Job #18945-8
This position will most likely start remotely. Will be required to work in the COUHES office when time and situation allows.
Internal Number: 18945
About MIT - COUHES
As an institution engaged in non-exempt human subjects research conducted or supported with federal funds, MIT is required to submit a written assurance of compliance with the Federal Regulations for the Protection of Human Subjects (45 CFR 46) as amended, approved by the Office for Human Research Protection (OHRP), Health and Human Services.
COUHES’s oversight of human subjects research is also guided by the Ethical Principles and Guidelines for the Protection of Human Subjects, generally known as the Belmont Report.
COUHES is responsible for the review of all research activities that involve human subjects, whether directly or indirectly, that will be conducted by investigators at or from MIT except for research that meet the criteria for exemption.
COUHES has authority to:
Approve, require modifications to secure approval of, defer action on or disapprove research protocols involving human subjects
Require progress reports from investigators
Oversee the conduct of research
Suspend or terminate approval of a study
Place restrictions on a study
Conduct reviews and inquiries regarding research activities as needed to obtain information necessary for the fulfillment of their responsibilities under the institutional Assurances