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UPMC Department of Medicine Division of Gastroenterology, Hepatology, and Nutrition is hiring a full-time Senior Regulatory Specialist to join their team in Oakland, PA. In this position, you will primarily work Monday-Friday during daylight hours. Some evenings or weekends could be needed occasionally to meet a deadline or attend a subject matter conference. Occasional travel to UPMC Shadyside or other locations in Oakland may be needed.

This position will work with faculty, staff, and industry. The ideal candidate will have excellent communication skills (written and oral) and will be comfortable presenting in front of a group, working in a fast-paced environment with deadlines, and understanding that change is the norm. A successful candidate will also be comfortable working with multiple types of software.

Purpose:

The Senior 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. In addition, the Senior Regulatory Specialist is tasked with training new regulatory staff, identifying departmental processes that require improvement and initiating discussion, performing administrative tasks as directed by and on behalf of the Regulatory Specialist Supervisor. Maintenance of the UPCI CTMA database is a crucial function of the position.

Responsibilities:

+ Consistently displays a level of professionalism in attitude, communication, and actions that is commensurate with management potential. Also, develops and maintains productive working relationships internally and externally by demonstrating accountability for their actions and their commitment to cancer research.

+ Performs any other tasks that are assigned by CRS management to help the organization meet its mission.

+ Takes responsibility for identifying his or her ongoing professional development needs and independently seeks resources and opportunities to meet those needs, such as through membership in oncology or research organizations.

+ Performs within the regulatory department with minimal to no supervision, acting as an information resource to all CRS staff and customers as well as acting on behalf of the Regulatory Specialist Supervisor when necessary.

+ Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral, and meeting format, adhering to appropriate timelines.

+ 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.

+ Uses a variety of resources and strategies to manage protocols as demonstrated by adherence to ethical practices during the conduct of clinical trials to protect the rights and well-being of patients, the collection of quality data, and the adherence to regulations concerning the conduct of human research as well as to all CRS SOPs.

+ Not only identifies opportunities for quality improvement, but also leads and actively participates in quality improvement efforts both at the departmental and organizational levels.

+ Demonstrates dedication to the professional development of others by continuously serving as a mentor or trainer to the regulatory staff; while also acting as a role model for the staff by adhering to all CRS SOPs as well as demonstrating good work ethics, time-management skills and promoting a healthy work environment.

+ Minimum BS degree required in a health, law, public health, business, science or related field.

+ Knowledge of clinical research trials regulations.

+ Minimum 2 years of research experience required.

+ Annual completion of a Director approved professional contribution

+ Commitment to obtain 15 Continuing Education Credits (CEUs) per year. At least 10 CEUs must be in regulatory in nature and 5 CEUs can be general research related. CEUs must be accredited be an appropriate education agency.

+ Leadership abilities

+ Solid/Strong/Good or higher on most recent performance evaluation (for internal applicants) and maintain in practice.

Licensure, Certifications, and Clearances:

+ Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran