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Clinical Trials - Qa

Advity Research
ADVITY Research
2-6 years
upto 9 LPA
5 Aug. 7, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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 Title: Clinical Trials - QA

Location: Hyderabad

Experience Required: 2 to 6 years

Employment Type: Full Time

Job Description:

  • Site Selection Audits: Plan and conduct investigator site selection audits and clinical trial study audits at investigator sites in accordance with applicable GCP guidelines and regulations.
  • Document Review: Review subject ICF and medical records.
  • CRF Design Review: Review the design of Case Report Forms (CRF).
  • SOP Review: Review standard operating procedures.
  • Audit Reporting: Issue audit reports to the investigator site staff and other concerned study personnel.
  • Audit Response Assessment: Review and assess the audit responses/CAPA and ensure timely closure of the audit report.
  • Compliance Updates: Provide regular updates of non-compliance or major findings in clinical trials to the Head of Quality Assurance.
  • Clinical Study Report Review: Review clinical study reports.
  • Timely Feedback: Provide document review comments in a timely manner.