The Clinical Trials Specialist manages cardiothoracic, vascular and surgical clinical trials in the Departments of Surgery and Cardiothoracic & Vascular Surgery. As a member of the management team, they are responsible for the general operations of departmental clinical trials including pre-study site selection, data monitoring, recruitment, maintaining strict adherence to protocols and supervising research personnel. Maintains compliance with all regulatory bodies associated with human subject research.
Bachelor's Degree in a quantitative or clinical field.
Minimum 3 years of experience working in a research or research related environment and be familiar with state and federal regulations and guidance applicable to human subject research (including 21 CFR 50 and 56, and 45 CFR 46, 21 CFR 312, 21 CFR 814 and 21 CFR 11 of the US Code of Federal Regulations). GCP as recommended by the FDA, and HIPAA.
Department: Cardiovascular and Thoracic Surgery Bargaining Unit:
Non Union Campus: MOSES Employment Status: Regular Full-Time Address: 3319 Rochambeau Avenue, Bronx
Shift: Day Scheduled Hours: 8 AM-4:30 PM Req ID: 106839
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