Senior Clinical Research Monitor (Remote) - Tisch Cancer Center

Job description

The Senior Clinical Research Monitor is responsible for performing ongoing internal reviews of research projects where human subject research is involved to ensure Investigators are compliant with federal regulations and guidelines governing clinical research, good clinical practices and institutional policies and procedures. The Senior Clinical Research Monitor mentors and advises less senior staff. - Performs ongoing internal reviews of regulatory and essential documents, standard operating procedures (SOP), subject case files, protocol compliance, data and safety monitoring, and pharmacy and/ or device documents (investigational product compliance)for IRB approved trials conducted by Tisch Cancer Institute. - Conducts Exit Conference with Investigator and research team staff to review observations. - Assist study teams in preparation for regulatory agency inspections and external audits. Participates in the conduct of agency inspections and external audits. Provides support to the Quality Assurance team, Principal Investigator, study team, and other key stakeholders before, during and after inspections and/ or audits. - Assists in the development of education materials, quality...