Location: New Haven, CT
Cap-Exempt H-1B Position — No lottery required
Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! **Overview** Reporting to the Assistant Director of Quality Assurance (QA) and Monitoring for the Yale Center for Clinical Investigation (YCCI), the YCCI Senior Clinical Research Associate conducts clinical research monitoring for clinical trials performed at the Yale School of Medicine and external (non-Yale) sites. Works directly and in collaboration with YCCI leadership, departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review the activities associated with human subjects research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions. Performs site qualification visits to determine the feasibility and appropriateness of a potential site before site selection. Working collaboratively with key stakeholders across the Yale School of Medicine, this role advocates for the advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies. The Senior Clinical Research Associate will be responsible for independently tracking, planning, ensuring the research activities are conducted in accordance with approved protocols and reporting monitoring activities. The Senior Clinical Research Associate will be responsible for developing project specific monitoring plans via evaluation of the project risk and in accordance with FDA guidance, as well as monitoring for multiple clinical trials. The monitoring activities performed include but are not limited to: Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close Out Visits per protocol specific monitoring pla