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Regulatory Affairs Coordinator

Description

Tharick Pascoal's lab focuses on performing sophisticated brain imaging techniques, blood analysis, cognitive testing, and clinical trials in human subjects. The neuroimaging aspect of our work involves patients undergoing magnetic resonance imaging and positron emission tomography. The fluid biomarker aspect of our work includes analysis of blood samples using cutting edge technologies such as Single molecule array (Simoa). The aim of this research is the development and validation of biomarkers capable of identifying the presence of Alzheimer’s disease and other dementias the development of novel therapeutic targets for neurodegenerative diseases. The Regulatory Affairs Coordinator will prepare Institutional Review Boards (IRBs) and FDA Investigational New Drug (IND) protocols for local studies as well as prepare applications central applications for multi-site studies when required. The Regulatory Affairs Coordinator will ensure that the clinical sites will comply with the protocols and regulations in several local and multi-sites studies.

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.

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:

  • Cardiopulmonary Resuscitation (CPR)
  • Comprehensive Crisis Management (CCMC)
  • Act 34
  • OAPSA

UPMC is an Equal Opportunity Employer/Disability/Veteran

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   Current UPMC employees must apply in HR Direct