Regulatory Affairs Analyst II

Written by spartanburg - - Comments Off on Regulatory Affairs Analyst II
Spartanburg Regional Medical Center
March 24, 2021
Spartanburg, South Carolina
Job Type


Regulatory Affairs Analyst II

  • Greer, SC
  • Gibbs Research Institute
  • Oncology Grants
  • Full-Time - Days - 8a-5p
  • Professional/Technical
  • Job Grade E10
  • Req #: 38926


Position Summary


Creates, submits, and maintains essential regulatory documentation for the Clinical Research Department per FDA/OHRP/ICH policies and guidelines. Communicates essential regulatory document changes to clinical research staff and investigators.  Advises and directs clinical research staff and investigators to ensure compliance with FDA/OHRP/ICH policies and guidelines.  Exhibits timely decision-making and effective priority setting skills; frequently works on complex and detailed processes and regulations. Assists with other duties as defined by Manager and Team Lead.


Minimum Requirements



  • Bachelor’s Degree and Two (2) to five (5) years’ experience in Clinical Research or Regulatory Affairs


  • Current certification as a clinical research professional or coordinator (SOCRA-CCRP, ACRP-CCRC or ACRP-CP, ACRP-CCRA, RAPS-RAC, CIP) with six (6) years’ experience in Clinical Research or Regulatory Affairs



  • See above



  • See above


Preferred Requirements


Preferred Education

  • Master’s degree


Preferred Experience

  • Five (5) to ten (10) years’ experience in Clinical Trials or Regulatory Affairs


Preferred License/Registration/Certifications   








Core Job Responsibilities


  • Reviews correspondence from sponsors to identify information that significantly and directly impacts patient care and/or other clinical research procedures
  • Gathers, analyzes, and disseminates IRB-approved documents for implementation adhering to departmental and sponsor timelines
  • Reviews, prioritizes, prepares, and submits protocol amendments to IRB of record adhering to departmental and sponsor timelines
  • Composes and submits Institutional Review Board materials such as initial application, Informed Consent forms, and subject recruitment materials
  • Liaises with study sponsors in a manner that enhances the reputation of the Clinical Research Department
  • Notifies research staff of protocol changes
  • Inspects, expedites, and submits protocol deviations and Serious Adverse Events (SAEs) to IRB of record per IRB policies
  • Verifies studies meet IRB standards for study closure; prepares and submits closure notification to IRB and other committees
  • Facilitates continuing approval of studies per IRB of record’s timelines
  • Utilizes eRegulatory Binder System, Florence, to provide accurate and current study documents to investigators and staff
  • Ensures radiation credentialing requirements and completion for applicable protocols are submitted
  • Collects and evaluates necessary information for reports, audits, grants, etc.
  • Attends and participates in Clinical Team Meetings
  • Other duties as assigned


Join our talent network to stay connected and hear about new opportunities.

Interested in working for Spartanburg Regional Healthcare System?

Join our talent network to stay connected and hear about new opportunities.

Related Jobs

Comments are closed.