Clinical Research Nurse Reviewer

MIT • Cambridge, MA

12d

About The Position

MIT's Institutional Review Board (IRB) - the Committee on the Use of Humans as Experimental Subjects (COUHES), ensures that clinical research is conducted according to best clinical practices and in compliance with federal, state, and local regulations governing human subjects research. This position has two primary responsibilities: (1) conducting clinical and ethical reviews of research protocols and (2) developing and delivering educational workshops and consultations for the research community. The core responsibility of this role is to review clinical research protocols and conduct visits to laboratory spaces to ensure that clinical research, including FDA-regulated device studies, is clinically sound, ethically appropriate, and aligned with best clinical practices and applicable regulatory requirements. In addition, the Clinical Research Nurse Reviewer will develop training materials and conduct interactive workshops on topics relevant to the research community. The individual will also provide one-on-one consultation sessions for new investigators joining the Institute, offering personalized guidance to help them initiate their research and address considerations specific to their research areas. This individual will also visit new laboratories or laboratories undergoing significant setup or configuration changes to provide consultation on lab setup.

Requirements

• Bachelor of Science in Nursing (BSN)
• Current Massachusetts Registered Nurse (RN) license
• A minimum of five years experience as nurse clinician including involvement in clinical research
• Familiarity with IRB processes and regulatory requirements
• Demonstrated ability to evaluate clinical procedures and identify potential risks to research participants
• Must obtain certification within one year of meeting the eligibility requirements for the certification exam.

Nice To Haves

• Master of Science in Nursing (MSN)
• Current Massachusetts NP license
• National Board Certification (NP)
• Five years of experience as clinical nurse practitioner
• Experience with FDA-regulatory medical device trials
• Experience participating in FDA audits or inspections from the investigator or institutional side
• Certification in Clinical Research (e.g. IACRN, CCRP, CCRC, CCRA, CIP)
• Understanding of relevant laws, guidelines, and ethical principles (e.g., 45CFR46, 21 CFR 50, 21CFR 56, 21CFR 812, 21CFR 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
• Organizational and time management skills
• Ability to manage multiple projects and meet deadlines in a fast-paced environment
• Experience with research administration and compliance
• Attention to detail: meticulous in reviewing documents and ensuring accuracy.

Responsibilities

• Conducting clinical and ethical reviews of research protocols.
• Developing and delivering educational workshops and consultations for the research community.
• Reviewing clinical research protocols.
• Conducting visits to laboratory spaces to ensure clinical research is clinically sound, ethically appropriate, and aligned with best clinical practices and applicable regulatory requirements.
• Developing training materials.
• Conducting interactive workshops on topics relevant to the research community.
• Providing one-on-one consultation sessions for new investigators.
• Visiting new laboratories or laboratories undergoing significant setup or configuration changes to provide consultation on lab setup.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level