Compliance Specialist

MIT•Cambridge, MA

6d•Onsite

About The Position

COMPLIANCE SPECIALIST 1 , Vice President for Research , to ensure compliance with federal, state, and local policies, and guidelines related to research protocols involving human subjects at MIT on behalf of the Committee on the Use of Humans as Experimental Subjects (COUHES). The primary responsibility is to ensure that research protocols are clinically sound, ethical, and aligns with best practices, minimizing participant risk while ensuring standard of care, clear informed consent, and appropriate recruitment and screening. Duties require on-campus presence to review study facilities and conditions. Full job description may be found at https://docs.google.com/document/d/1gblKXkZQbgxD0y-NJsImK5A_4DmdL6MF/edit .

Requirements

Bachelor of Science in Nursing (BSN)
current Massachusetts RN/NP license
National Board Certification (NP)
minimum of five years of experience as nurse clinician and/or clinical nurse practitioner including involvement in clinical research
familiarity with IRB processes and regulatory requirements

Nice To Haves

Master of Science in Nursing (MSN)
Certification in Clinical Research (e.g. IACRN, CCRP,ACRP, SOCRA)
understanding of relevant laws, guidelines, and ethical principles (e.g., 45 CFR Part 46, 21 CFR 50, 21CFR 56, 21CFR 812, 21CFR 312, ICH-GCP)
strong analytical and critical thinking skills
understanding of relevant laws, guidelines, and ethical principles (e.g., 45 CFR Part 46, 21 CFR 50, 21CFR 56, 21CFR 812, 21CFR 312, ICH-GCP)
ability to assess research protocols and identify potential risks to human subjects
excellent communication and interpersonal skills
ability to communicate effectively with researchers, IRB members, and other stakeholders
ability to manage multiple projects and meet deadlines in a fast-paced environment
experience with research administration
experience with FDA-regulatory and industry-sponsored trials