Description

Purpose:

UPMC Hillman Cancer Center is currently hiring a regular full-time Regulatory Specialist to help support the Medical Oncology Clinical Research Services team located within the Hillman Cancer Center in Shadyside/Pittsburgh, PA.  This role will support various disease center programs working Monday through Friday daylight hours.

The Regulatory Specialist's purpose is to review and process safety and compliance events, prepare forms/documents for submission to regulatory authorities, facilitate a monthly Data Safety & Monitoring Board meeting with research staff and physicians, and to maintain the regulatory integrity of assigned clinical trial safety events under the direction of the Regulatory Specialist Supervisor. Maintenance of the UPCI CTMS database is a crucial function of the position.

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 safety and compliance events, preparing and submitting reportable events to regulatory authorities, as well as preparing and reporting all safety and compliance events at monthly disease centers Data Safety and Monitoring Board meetings.
• Maintains an organized and accessible regulatory file for site audit/monitoring visits, as per UPCI SOP.
• Participate in pre-submission review committees for investigator-initiated trials to ensure inclusion of safety event reporting language and study drug side effects, in accordance with CRS SOPs and FDA regulation and guidance.
• 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.

Qualifications

• 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:

• Act 34


• UPMC is an Equal Opportunity Employer/Disability/Veteran

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