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Spartanburg Regional Healthcare System Regulatory Affairs Analyst II (Clinical Research) in Spartanburg, South Carolina

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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