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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.
Required Education and Experience:
Bachelor’s degree in a related field. Six years of related experience or an equivalent combination of education and experience.
Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.
Demonstrable understanding of clinical research processes and procedures from study start-up to study close out with an experience as a clinical research auditor, clinical research associate or equivalent. Extensive knowledge and application of auditing or monitoring techniques and practices.
Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.
Organized with the capability of handling multiple/diverse projects simultaneously. Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule.
Superior interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
Preferred Education and Experience: Master’s Degree in related field. Experience in auditing or monitoring of clinical trials.
Application: For more information and immediate consideration, please apply online at https://bit.ly/YaleCareers-63936BR. Please be sure to reference this website when applying for this position.
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.
Yale University considers applicants for employment without regard to and does not discriminate on the basis of an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression.
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.