- Department: Clinical Research Admin and Support
- Schedule - Shift - Hours: Full-Time - Days - 8:30am-5:00pm
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
License/Registration/Certifications
Preferred Requirements
Preferred Education
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
Additional Information
Spartanburg Regional Healthcare System (SRHS) offers a full spectrum of services through six hospital campuses: Spartanburg Medical Center, Spartanburg Medical Center — Mary Black Campus, Pelham Medical Center, Cherokee Medical Center, Spartanburg Hospital for Restorative Care and Union Medical Center. SRHS also includes Ellen Sagar Nursing Center and Woodruff Manor. SRHS provides unparalleled cancer care through Gibbs Cancer Center & Research Institute, with locations in Spartanburg, Greer, Union and Gaffney. The multidisciplinary Medical Group of the Carolinas has more than 600 physicians across Upstate South Carolina and western North Carolina. SRHS employs more than 9,000 associates and offers outpatient surgery centers and a Level I Trauma Center.
Founded on Aug. 29, 1921, as Spartanburg General Hospital, Spartanburg Regional celebrates over 100 years of excellence.
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