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UPMC continues to comply with governmental guidance related to local, state, and federal COVID-19 vaccination for employment. All employees and affiliated staff of UPMC entities are considered essential health care workers and will be accountable to follow the Centers for Medicare & Medicaid Services (CMS) federal vaccine mandate. To be compliant with the federal mandate, employees must complete the approved vaccination dosage regimen currently defined by the federal government. Compliance with the federal mandate is encouraged before hire. Medical and religious exemption requests may be submitted for consideration.

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

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Regulatory Affairs Coordinator

  • Job ID: 691967171
  • Status: Full-Time
  • Regular/Temporary: Regular
  • Hours:
  • Shift: Variable
  • Facility: UPMC Children's Hospital of Pittsburgh
  • Department: Research Administration
  • Location: 4401 Penn Avenue, Pittsburgh PA 15224
  • Union Position: No
  • Salary Range: $24.78 to $42.84 / hour

Description

The Regulartory Affairs Coordinator will serve as a resource to investigators regarding preparation of protocols or submission to various review entities. The coordinator will develop protocols for Institutional Review Board submission and maintain regulatory records for existing protocols assigned by the Department's supervisor.

Responsibilities:

  • Computer aptitude necessary to operate word processing, spreadsheets, etc. applications.
  • Submit adverse event reports and safety reports to the IRB.
  • Oversee processing of all protocol amendments in a timely matter.
  • Facilitate processing and approval for cooperative group trails (GOG) new protocols and amendments.
  • Prepare protocols for submission to Institutional Review Boards, (University of Pittsburgh Medical Center, University of Pittsburgh Cancer Institute and Magee-Womens Hospital).
  • Responsible for following the mandatory reporting procedures for any incident or serious event that did affect or potentially could have affected the clinical care of any patient.
  • Assist in submitting new IND applications to the FDA.
  • Submit termination notices and final progress reports to the IRB.
  • Notify investigators and coordinators once approval has been obtained.
  • Process annual renewals with all of the Institutional Review Boards.
  • Assist in preparation and submission of pre-study regulatory documentation to pharmaceutical.
  • Communicate approval to appropriate individuals at cooperative group headquarters.
  • Review and distribute the IRB's feedback to investigators.
  • Track the status of all protocols, from initial IRB submissions until final approval.
  • Prepare modifications for the IRB, revise protocol summaries and consent forms and complete the necessary steps for resubmission to the Board.
  • Assist in submission for UPMC General Clinical Research Committee and Magee-Womens Hospital Clinical Research Center.
  • Demonstrated regulatory skills, including knowledge of local and federal IRB submission processes.
  • Knowledge of regulatory guidelines.
  • Interpersonal and communication skills necessary to establish and maintain effective relationships with staff, investigators and Institutional Review Boards.

 

Qualifications

  • Level of knowledge equivalent to that ordinarily acquired through completion of a BSN or Bachelor's Degree in related field.
  • Two years experience in Research and Regulatory Affairs division.
  • Successful demonstration of the completion of the competencies required by the department/unit.
  • This individual must be able to demonstrate the knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by his/her assigned unit as specified below.
  • They must also demonstrate knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient's status and interpret the appropriate information needed to identify each patient's requirements relative to his/her age-specific needs and to provide the care needs as described in the department's policy and procedures.


Licensure, Certifications, and Clearances:

  • Act 31 Clearance with renewal
  • Act 33 Clearance with renewal
  • Act 34 Clearance with renewal
  • Act 73 FBI Clearance with renewal


UPMC is an Equal Opportunity Employer/Disability/Veteran

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   Current UPMC employees must apply in HR Direct