Clinical Research Compliance Specialist

thical, 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.

The full job description is available, here.

Job Requirements

REQUIRED: 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. PREFERRED: 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, 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; and experience with FDA-regulatory and industry-sponsored trials.

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