Clinical Research Regulatory Affairs Associate

13 Nov, 2020

Jobs

Clinical Research Regulatory Affairs Associate

St Jude Children's Research Hospital
Memphis, TN

Overview

As the Clinical Research Regulatory Affairs Associate, you will be responsible for assisting the coordination of the clinical research components for investigational products under the purview of the Food and Drug Administration (FDA), Recombinant Advisory DNA Committee (RAC) and Office of Biotechnology Activities (OBA). We are an “all-in” type of culture and you will play a key role in keeping our standards high for clinical research activities. This type of work involves you gaining rapport and credibility with internal and external stakeholders. Responsibilities include the following:

  • Assist study teams with creation and approval of drug/biologic/device applications for IND and IDE phase I and early phase 2 studies
  • Collect data necessary for regulatory submissions
  • Maintain the clinical trials regulatory compliance program to assure adherence to local, state and federal regulations, and institution policies and procedures for the responsible conduct of institutional clinical research activities.
  • Track reportable events such as protocol violations/deviations, adverse event and serious adverse events
  • Represent St. Jude as a point of contact to the external regulatory authorities for questions and issues regarding specific applications
  • Coordinate with St. Jude research staff to improve the quality of applications
  • Propose improvements to the regulatory application process

Acting as a liaison with FDA project managers, you communicate regularly and provide feedback to St. Jude study teams. You will have the opportunity to be on the cutting edge with experimental studies with direct principal investigator interaction. Take the first step to join our team by applying now!

Minimum Education

  • Bachelor’s degree in scientific, healthcare or related field required

Minimum Experience

  • Three (3) of research and/or regulatory compliance experience in a scientific or healthcare related field required
  • Experience with federal research compliance regulations (e.g., NIH, OHRP, FDA, CMS, USDA, OSHA and/or OBA) required

No Search Firms:

St. Jude Children’s Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

Learn more here

Job posted: 2020-11-13