The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Yale School of Medicine and Yale Center for Clinical Investigation (YCCI) is expanding its clinical research administration and clinical trials operations team. There are currently several exciting opportunities to join our staff and help direct Yale’s clinical research enterprise as it continues to grow. The Yale School of Medicine oversee thousands of studies annually. YCCI is the administrative hub for Yale’s Clinical and Translational Science Award (CTSA), providing support for research across Yale University, Yale Medicine, and the Yale New Haven Health System, which includes one of the largest hospitals in the nation. For more information please visit https://medicine.yale.edu/ycci/about/job-opportunities/
Reporting to the Assistant Director of Quality Assurance (QA) and Monitoring for YCCI, the incumbent conducts clinical research monitoring for clinical trials conducted at the Yale School of Medicine and external (non-Yale) sites.
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 plans. The Senior Clinical Research Associate may be responsible for management and oversight of protocol specific Data and Safety Monitoring Boards.
The mission of the Office of QA & Monitoring within YCCI is to foster a supportive environment conducive to achieving Yale’s clinical research mission and provide a central resource to aid investigators, research groups and leadership with respect to trial development, execution, and oversight.
Frequent travel, beyond CT, is required.
This position will be partially funded by the sponsored awards it supports.
Internal Number: 63936BR
About Yale University
Since its founding in 1701, Yale University has been dedicated to expanding and sharing knowledge, inspiring innovation, and preserving cultural and scientific information for future generations. Yale’s reach is both local and international. It partners with its hometown of New Haven, Connecticut to strengthen the city’s community and economy. And it engages with people and institutions across the globe in the quest to promote cultural understanding, improve the human condition, delve more deeply into the secrets of the universe, and train the next generation of world leaders.
Yale offers exciting opportunities for achievement and growth in New Haven, Connecticut. Conveniently located between Boston and New York, New Haven is the creative capital of Connecticut with cultural resources that include three major museums, a critically-acclaimed repertory theater, state-of-the-art concert hall, and world-renowned schools of Architecture, Art, Drama, and Music.
We invite you to discover the excitement, diversity, rewards and excellence of a career at Yale University. One of the country's great workplaces, Yale University offers exciting opportunities for meaningful accomplishment... and true growth. Our benefits package is among the best anywhere, with a wide variety of insurance choices, liberal paid time off, fantastic family and educational benefits, a variety of retirement benefits, extensive recreational facilities, and much more.