COVID-19 Vaccination Information

Across UPMC, our guiding principle is to always prioritize the safety of our employees, patients, and members. UPMC believes that vaccination is important, helps protect all, and advocates that everyone who can be vaccinated should be vaccinated.

UPMC complies with all governmental requirements related to local, state, and federal COVID-19 vaccination for employment. The Jan. 13 Supreme Court of the United States decision that the Centers for Medicare & Medicaid Services federal COVID-19 vaccine mandate will move forward requires UPMC to ensure employees either get vaccinated or receive a requested medical or religious exemption.

If you are not yet vaccinated, we urge you to get a vaccine now. You can schedule your COVID-19 vaccination through UPMC or visit a non-UPMC provider or UPMC Urgent Care location.

Proof of vaccination is not required upon hire; however, employees will be responsible for ensuring post-hire compliance by getting vaccinated or requesting a medical or religious exemption.

For more information about UPMC’s response to COVID-19, please visit UPMC.com/coronavirus.

Search Our Jobs

   Current UPMC employees must apply in HR Direct

Regulatory Specialist

  • Job ID: 018942976
  • Status: Full-Time
  • Regular/Temporary: Regular
  • Hours:
  • Shift: Day Job
  • Facility: Corporate Finance
  • Department: Spons Progr and Res Sup
  • Location: 3600 Forbes Ave, Pittsburgh PA 15213
  • Union Position: No
  • Salary Range: $24.78 to $42.84 / hour

Description

Do you have a strong research background and are looking for the next step in your career?  Look no further!  UPMC Corporate Services is hiring a Regulatory Specialist. This position will operate in a hybrid work-from-home model and will offer some remote flexibility. Apply today! 

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 UPCI CTMS database is a crucial function of the position.

UPMC has a Center for Engagement and Inclusion that is charged with executing leading-edge and next-generation diversity strategies to advance the organization’s diversity management capability and its national presence as a diversity leader. This includes having Employee Resource Groups, such as Women Inspiring Talent in Heath Care in Finance (WITH) or PRIDE Health, that support the implementation of our diversity strategy. 

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.

 

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 trials 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 data base 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

Total Rewards

More than just competitive pay and benefits, UPMC’s Total Rewards package cares for you in all areas of life — because we believe that you’re at your best when receiving the support you need: professional, personal, financial, and more.

Our Values

At UPMC, we’re driven by shared values that guide our work and keep us accountable to one another. Our Values of Quality & Safety, Dignity & Respect, Caring & Listening, Responsibility & Integrity, Excellence & Innovation play a vital role in creating a cohesive, positive experience for our employees, patients, health plan members, and community. Ready to join us? Apply today.

   Current UPMC employees must apply in HR Direct