Clinical Research Compliance Specialist

CLINICAL RESEARCH COMPLIANCE SPECIALIST

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 aligned 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.

• Bachelor of Science in Nursing (BSN); current Massachusetts RN license; minimum of five years of experience as nurse clinician including involvement in clinical research; and familiarity with IRB processes and regulatory requirements.

• Master of Science in Nursing (MSN); current Massachusetts NP license;
  National Board Certification (NP); minimum of five years of experience as clinical nurse practitioner;
• 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, 21
  
  CFR 56, 21
  
  CFR 812, 21
  
  CFR 312, ICH-GCP);
• Strong analytical and critical thinking skills;
• 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.