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Clinical Trials- Qa

Advity Research
ADVITY Research
2-6 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Discription 

  • Plan and conduct investigator site selection audits and clinical trial study audits at investigator sites in accordance with applicable GCP guidelines and regulations.
  • Review of subject ICF and medical records
  • Review of CRF design
  • Review of standard operating procedures
  • Issue audit reports to the investigator site staff and other concerned study personnel
  • Review and assess the audit responses/CAPA and closure of the audit report in a timely manner.
  • Provide regular updates of non-compliance or major findings in clinical trials to the Head-Quality Assurance
  • Review of Clinical study report
  • Provide document review comments in a timely manner.