Position Summary The Lead Regulatory Coordinator for the Stony Brook Cancer Center Clinical Trials Department is a new and important role within the department, responsible for the supervision of all regulatory staff within the department as well as all aspects involving the regulatory requirements for all studies and clinical trials. The Lead Regulatory Coordinator will be preparing and submitting protocols and supporting documents to regulatory bodies such as PRMC and Institutional Review Board (IRB). In addition, the Lead Regulatory Coordinator can be called upon to represent the Cancer Clinical Trials office when meeting with pharmaceutical companies, they will attend team meetings, work with other staff to insure all regulatory documents and requirements are met and up to date, provide strategies for improving efficiency, action plans and plans to improve quality; provide training and education of personnel; participate in internal auditing of regulatory items as well as ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Duties of a Lead Regulatory Coordinator may include the following but are not limited to: Provides supervision of regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC and IRB. Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies. Responds to all questions from the IRB related to the regulatory aspects of the study. Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials. Meets with monitors from pharmaceutical companies and represents the Stony Brook Cancer Center Clinical Trials Office during these meetings. Works closely with the Clinical Trial Study Coordinator, research staff and investigators to assure that all regulatory documents for the research studies are up-to-date. Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments. May provide training and education to other personnel and participate in centralized activities of the department or institution. May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs, including identifying quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. Ensures compliance with all federal and local agencies including the FDA and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines, strict patient confidentiality according to HIPAA regulations and applicable law and participates in required training and education programs. Qualifications Required Qualifications: BA/BS Degree. 5 or more years of directly related experience. In lieu of BA/BS Degree, a combination of higher education and additional years of directly related experience totaling 7 years will be considered. Special Notes: Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises. All Hospital positions are subject to changes in pass days and shifts as necessary. This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair. The selected candidate must successfully clear a background investigation. Prior to start date, the selected candidate must meet the following requirements: Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services (The hiring department will be responsible for any fee incurred for examination), submit (3) written references, and provide a copy of any required New York State license(s)/certificate(s). Please be advised that failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer. The best ideas in medicine start with the best people. At Stony Brook Medicine, our highest calling is to put the power of ideas to work in our patients' lives. Stony Brook Medicine integrates and elevates all of our health-related initiatives: education, research and patient care. Stony Brook Medicine is Long Island's premier academic medical center. With 603 beds, we serve as the region's only tertiary care center and Level 1 Trauma Center, and are home to the Stony Brook Heart Institute, Stony Brook Cancer Center, Stony Brook Children's Hospital, Stony Brook Neurosciences Institute, and Stony Brook Digestive Disorders Institute. We also encompass Suffolk County's only Level 4 Regional Perinatal Center, state-designated AIDS Center, state-designated Comprehensive Psychiatric Emergency Program, state-designated Burn Center, the Christopher Pendergast ALS Center of Excellence, and Kidney Transplant Center. It is home of the nation's first Pediatric Multiple Sclerosis Center. Stony Brook University is an Affirmative Action/Equal Opportunity employer. We are committed to the creation of a diverse and inclusive campus climate. We encourage protected veterans, individuals with disabilities, women and minorities to apply. This function/position has been designated as
Internal Number: 1802825
About Stony Brook University
FROM ITS BEGINNINGS A HALF-CENTURY AGO, STONY BROOK UNIVERSITY HAS BEEN CHARACTERIZED by innovation, energy and progress, transforming the lives of people who earn degrees, work and make groundbreaking discoveries here. A dramatic trajectory of growth has turned what was once a small teacher preparation college into an internationally recognized research institution that is changing the world.