Regulatory Affairs Analyst II

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Spartanburg Regional Medical Center
Published
March 24, 2021
Location
Spartanburg, South Carolina
Job Type

Description

Regulatory Affairs Analyst II

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

Summary

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

 

Education

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

OR

  • 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

 

Experience

  • See above

 

License/Registration/Certifications       

  • 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   

  • RAC, CCRA, CCRP, CCRC, or CIP

 

 

 

 

 

 

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
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