Research Regulatory Associate, Early Drug Development
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About The Position
The Research Regulatory Associate position at Memorial Sloan Kettering Cancer Center (MSK) offers an exciting opportunity to join the Early Drug Development service, specifically within MSK's phase 1 research team. This role is pivotal in supporting the regulatory management of research protocols, ensuring that MSK maintains its commitment to high standards of clinical research and compliance with regulatory requirements. The successful candidate will be responsible for performing all tasks associated with the regulatory management of research protocols, which includes maintaining up-to-date regulatory documents and files to ensure that MSK is always audit-ready. In this role, the Research Regulatory Associate will develop, revise, and maintain accurate protocol tools, ensuring the accurate conduct of clinical research at all times. The position also involves participation in special projects and task forces as applicable, contributing to the overall mission of MSK in advancing cancer research and treatment. The ideal candidate will possess a strong understanding of regulations pertaining to human subject protection, including 21 CFR and 45 CFR 46, as well as the Health Insurance Portability and Accountability Act (HIPAA). The role requires outstanding attention to detail, strong analytical and interpersonal skills, and the ability to plan and prioritize work effectively to meet organizational goals. Critical thinking and problem-solving skills are essential to handle unforeseen issues appropriately and resolve them in a timely manner. Excellent communication skills are necessary to interact confidently and professionally across all levels of the organization. Enthusiasm and dedication to MSK's vision, mission, and values are also key attributes for success in this position.
