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Regulatory Affairs Analyst
Job Number:
44100597
Company Name:
Spartanburg Regional Healthcare System
Job Location:
Spartanburg, SC US
Job Category:
Healthcare & Medical
Regulatory Affairs Analyst
Regulatory Affairs Analyst Department: Research Institute Schedule: Full-Time Shift: Hours: 8a-4:30p Job Grade E7 Job Details: * GED or High School Diploma required *
POSITION SUMMARY
Responsible forcreating, submitting, and filing regulatory documents, including serious adverse events for the Research Division and CCOP. Responsible for submitting documents to the IRB and creating and updating informed consents under the direction of the Regulatory Affairs Manager and Clinical Research Director. Assist with CCOP duties as defined by Clinical Research Director.
EDUCATION REQUIREMENTS
Required:
High School Diploma
Preferred:
Bachelors (can substitute equivalent experience)
EXPERIENCE REQUIREMENTS
Required:
5-8 years experience in Clinical Trials or Regulatory Affairs
Preferred:
CERTIFICATIONS, LICENSES and/or REGISTRATIONS
Required:
RAC, RAPS, CCRA, or ACRP required within three years of employment
Preferred:
OTHER REQUIREMENTS
§ Working knowledge of FDA/OPRR/GCP/ICH guidelines § MS office experience § Attention to detail, excellent organizational skills. § Excellent knowledge of medical terminology § Must have knowledge with OHRP guidelines § Must have knowledge of Institutional Review Board guidelines, processes and policies § Experience with FDA documents required § Experience with Informed Consent writing required § Must be meticulous with detail
