Hybrid IRB Compliance Specialist: Ethics & Regulatory Reviews

Massachusetts Institute of Technology

Cambridge (MA)

Hybrid

USD 90.000 - 120.000

Vollzeit

Vor 13 Tagen

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Zusammenfassung

Massachusetts Institute of Technology seeks an Institutional Review Board (IRB) Compliance Administrator in the Office of the Vice President for Research. The role focuses on ethical and regulatory reviews of human subject research, acting as a primary reviewer and POC for investigators.

You will produce protocol summaries, advise on documentation modifications, and help with outreach and education. The position requires a bachelor’s degree and at least three years of related experience, with

Qualifikationen

  • REQUIRED: Bachelor's degree in related field
  • Minimum of three years of human subjects research experience
  • Experience with FDA regulated device research and knowledge of federal/state regulations for human subject research
  • Excellent analytical, organizational, and written and oral communication skills
  • Understanding of research procedures terminology, clinical trials, and data management
  • Experience conducting and managing human subject research in an academic setting
  • Attention to detail; discretion with confidential information
  • Ability to multitask and prioritize in a fast-paced environment and collaborate with faculty, staff, and institutional representatives

Aufgaben

  • Conduct ethical and compliance reviews to ensure regulatory compliance for use of human subjects in research.
  • Serve as POC and compliance reviewer of human subject research protocols; identify regulatory issues and risks to participants.
  • Independently review expedited and primary reviews; prepare high-level protocol summaries; coordinate ancillary reviews.
  • Advise investigators on regulatory applicability and modifications to study documentation.
  • Assist with committee minutes, COUHES Connect, and educational materials/workshops.

Kenntnisse

Analytical skills
Organizational skills
Written & oral communication
Attention to detail
Discretion with confidential info
Multitasking & prioritization
Collaboration with faculty & staff
FDA regulatory knowledge

Ausbildung

Bachelor's degree in related field
CIP certification

Jobbeschreibung

Massachusetts Institute of Technology seeks an Institutional Review Board (IRB) Compliance Administrator in the Office of the Vice President for Research. The role focuses on ethical and regulatory reviews of human subject research, acting as a primary reviewer and POC for investigators.

You will produce protocol summaries, advise on documentation modifications, and help with outreach and education. The position requires a bachelor’s degree and at least three years of related experience, with

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