Regulatory Specialist - (Oncology)

UPMC; Pittsburgh (Allegheny County); On-site; USD 60,000 - 80,000; Full time

Job summary

UPMC Hillman Cancer Center is seeking a full-time Regulatory Specialist to support the Oncology Clinical Research Services team. The role involves managing regulatory documents, ensuring compliance throughout clinical trials, and maintaining the integrity of assigned projects. The ideal candidate will bring experience in clinical trials and a collaborative mindset to facilitate compliance across multiple studies.

Qualifications

• Experience in clinical trials and regulatory submission processes.
• Strong organizational skills for maintaining regulatory files.
• Ability to liaise effectively with sponsors and internal teams.

Responsibilities

• Manage protocols ensuring compliance with procedures and reporting requirements.
• Liaise with sponsors and investigators, providing trial updates.
• Actively participate in quality improvement efforts within the organization.

Skills

Regulatory compliance

Protocol management

Communication

Education

Bachelor's degree in a related field

Job description

Purpose:

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-timeRegulatory Specialistto help support the Oncology Clinical Research Services team located at the Hillman Cancer Center in Shadyside/Pittsburgh, PA. This role willfocus on Informed Consent Form negotiations, which will expedite the clinical trial activation process while working 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 UPCI SOP.
• 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.