Clin Rsearch Reg Spt Spc II at University of Rochester

Job description

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. Job Location (Full Address): 601 Elmwood Ave, Rochester, New York, United States of America, 14642 Opening: Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400119 Surgery-Cancer Control Work Shift: UR - Day (United States of America) Range: UR URG 108 Compensation Range: $52,300.00 - $73,300.00 The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Responsibilities: The Clinical Research Regulatory Support Specialist II oversees the conduct of our affiliated NCORP sites throughout the nation, regularly reviewing their research activities to ensure activities adhere to Research Base SOPs, the approved clinical research protocol, CTMB guidelines and federal regulations. The URCC NCORP Research Base is a large, complex, and dynamic operation involving many investigators, cross-functional teams, and laboratories. This program is funded by a $40M NIH grant and provides the infrastructure to conduct large multi-site cancer control and cancer care delivery clinical trials within our national network. The Research Base’s network is comprised of over 800+ community oncology practices and thousands of oncologists, advanced practice providers, pharmacists, administrators, research nurses, clinical research coordinators, data managers, regulatory specialists, and quality assurance staff nationwide. The Research Base portfolio includes prospective, cohort, and longitudinal Phase II – III randomized clinical trials. As the Lead Auditor for the NCORP Research Base and working with the Manager, Clinical Research Quality & Education, this position is responsible for quality assurance and auditing activities. The incumbent, using the required advanced degree of experience and working knowledge required of the role, informs and authors SOPs, independently creates educational and training materials and spreadsheets tracking key program metrics. This role educates and ensures compliance of all Research Base personnel and external scientific collaborators in best quality assurance practices and federal regulations. Using the high degree of independence and autonomy required of this role, the incumbent must also be capable of covering for both the Manager, Clinical Research Quality & Education (their manager) and the Regulatory Specialists (their peers). The URCC NCORP Research Base is part of the Department of Surgery, Division of Supportive Care in Cancer with our offices being located in the Saunders Research building. This role is required to be in-office, with work hours/availability during standard business hours, within approximately 8:00am – 5:00pm. Occasional work outside of standard business hours may be required. Some travel may be required but is currently limited to approximately 1 to 2 meetings or conferences annually. Travel may periodically be required to perform on-site monitoring visits throughout our national network if the inspection is unable to be completed remotely. ESSENTIAL FUNCTIONS Auditing Responsibilities: Establishes the schedule of monitoring visits to 30+ off‐site affiliates of the NCORP Research Base in accordance with National Cancer Institute Clinical Trials Monitoring Branch (CTMB) Guidelines; notifies sites; assembles audit teams; arranges details of the visit; prepares materials, reviews all regulatory