Regulatory Specialist - (Breast Ctr.) - Oncology

Purpose:

UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region's only comprehensive cancer center designated by the National Cancer Institute. As the preeminent institution in western Pennsylvania for the delivery of cancer care, the performance of basic, translational, and clinical research, and the education of the next generation of cancer researchers and physicians, UPMC Hillman Cancer Center is exceptionally well-positioned to contribute to the global effort to reduce the burden of cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time Regulatory Specialist to help support the Oncology Clinical Research Services team located at the Hillman Cancer Center in Pittsburgh, PA. This role will support the Breast Oncology Disease Center program study working a Hybrid schedule with Monday through Friday daylight hours. The Regulatory Specialist's purpose is to develop regulatory forms/documents using assigned clinical study materials, to usher clinical studies through the regulatory portion of the trial submission process, and to maintain the regulatory integrity of assigned clinical trials from approval to closure under the direction of the Regulatory Specialist Supervisor. Maintenance of the CTMS database is a crucial function of the position. The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology-focused trials at Hillman. These trials include institutional (investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the

FDA, IRB

processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing.

Responsibilities:

Uses a variety of resources and strategies to manage protocols and to ensure compliance with protocol procedures and all reporting requirements as well as adherence to all CRS SOPs. Develops and maintains productive working relationships internally and externally by demonstrating accountability for actions, enthusiasm, motivation, and commitment to patients and colleagues. Performs any other tasks that are assigned by CRS management to help the organization meet its mission. Understands the ancillary UPMC committees, various regulatory agencies and sponsor submissions as per their guidelines.

This includes an understanding of:

preparing, submitting and tracking protocol requirements through the initial approval process, preparing and submitting modifications, annual renewals, annual reports, and fiscal forms, as well as preparing and reporting all safety and compliance events. Maintains an organized and accessible regulatory file for site audit/monitoring visits, as per UPMC policies. Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral, and meeting format, while adhering to appropriate timelines. Supports the development of new staff and colleagues, may also serve as a preceptor. Understands the process for compiling disease center Data Safety & Monitoring Board (DSMB) meeting agendas and recording, disseminating, and submitting the minutes from the meeting to the appropriate regulatory bodies. Not only identifies opportunities for quality improvement, but also actively participates in quality improvement efforts both at the departmental and organizational levels. Acts as a resource concerning regulatory information for all internal and external customers. Bachelor's degree in a health, law, public health, business, science or related field OR equivalent combination of education and/or related experience required. Knowledge of clinical research trial regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential. OR 1+ years' experience in drug development, regulatory or clinical operations functions is preferred. Exceptional writing, planning, and organizational skills are required to prepare clinical study protocols, regulatory submissions, and various scientific and medical-related reports to contribute to the overall Clinical and Regulatory effort for oncology trials. Preparation and maintenance of FDA submissions and the ability to appropriately summarize data for inclusion in requisite reports is necessary. Previous work or strong knowledge of oncology is preferred. Strong communication, presentation and computer, and database knowledge skills are required. Must be capable of functioning independently with minimal supervision as well as perform and follow up with multiple projects.

Licensure, Certifications, and Clearances:

UPMC is an Equal Opportunity Employer/Disability/Veteran