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.

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Regulatory Specialist

  • Job ID: 916680933
  • Status: Full-Time
  • Regular/Temporary: Regular
  • Hours: Monday - Friday, daylight
  • Shift: Day Job
  • Facility: University of Pittsburgh Physicians
  • Department: 60314 POP23 SURG Oncology Research
  • Location: 3471 Fifth Avenue, Pittsburgh PA 15213
  • Union Position: No
  • Salary Range: $24.78 to $42.84 / hour

Description

University of Pittsburgh Physicians Division of Colon and Rectal Surgery is seeking a Full-Time Regulatory Specialist!

Ideally you would have experience with medical knowledge, EPIC, research experience, understanding of the regulatory process, strong attention to detail, the ability to work independently, and are able to answer questions related to your position.

You would work a Monday to Friday schedule from 8:00am to 4:30pm. This position will work at UPMC Passavant in McCandless (Monday and Tuesday) and the Kaufmann Medical Office Building in Oakland (Wednesday, Thursday, Friday).

Purpose:
Prepare regulatory documentation. Coordinate the submission and evaluation of clinical studies by regulatory processes from study approval to closure. Develop clinical protocols to maintain regulatory compliance. Maintain research and clinical databases

Responsibilities:

  • Entering data as it applies to the rectal cancer spreadsheet and database to ensure the accurate development of related studies and recording of treatment sequencing.
  • Interact and facilitate the training of med students to participate in our projects. 
  • Be the primary contact for research projects in collaboration with the MDs in department.
  • Maintain our database, enter surgeries into the CRS database.
  • Participate in research, staff, and multi-disciplinary meetings.
  • Perform database queries/searches to identify patient populations studied for clinical follow-up and disseminate results to all appropriate parties.
  • Complete and maintain required training for clinical research and database management including IRB certification modules.
  • Liaise with other departments as needed.

 

Qualifications

  • Bachelor of Science (BS) degree required in a health, public health, business, science, or related field.
  • One year experience in clinical or scientific research functions preferred. 
  • Knowledge of clinical research regulations including Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA).
  • 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.
  • Preparation and maintenance of IRB submissions and the ability to appropriately summarize data for inclusion in requisite reports is necessary.
  • Position requires either previous clinical research experience or combined experience in clinical, scientific, and administrative positions, along with a strong working knowledge of study design.
  • 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.


Licensure, Certifications, and Clearances:

  • Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran

Individuals hired into this role must comply with UPMC’s COVID vaccination requirements upon beginning employment with UPMC. Refer to the COVID-19 Vaccination Information section at the top of this page to learn more.  

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 PRIDE Health or UPMC ENABLED (Empowering Abilities and Leveraging Differences) Network, which support the implementation of our diversity strategy.

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   Current UPMC employees must apply in HR Direct