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Clinical Trials - Qa

2-6 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s a detailed and organized version of the job responsibilities:


Job Responsibilities

1. Site and Study Audits

  • Plan and conduct investigator site selection audits and clinical trial study audits at investigator sites.
  • Ensure audits are in compliance with applicable Good Clinical Practice (GCP) guidelines and relevant regulations.

2. Documentation Review

  • Review subject Informed Consent Forms (ICF) and associated medical records.
  • Assess the design and functionality of Case Report Forms (CRF).
  • Review and ensure the adequacy of Standard Operating Procedures (SOPs).

3. Audit Reporting and Follow-Up

  • Issue comprehensive audit reports to investigator site staff and other relevant study personnel.
  • Review and assess audit responses and Corrective and Preventive Actions (CAPA) to ensure timely closure of audit reports.

4. Compliance and Reporting

  • Provide regular updates on instances of non-compliance or significant findings in clinical trials to the Head of Quality Assurance.
  • Review clinical study reports to ensure compliance with established guidelines.

5. Timely Feedback

  • Offer clear and actionable document review comments to teams and stakeholders within established timelines.

This role is pivotal in ensuring clinical trials maintain the highest standards of compliance, accuracy, and reliability.

Would you like to add specific qualifications or experience requirements for the position?