Clinical Trail QA Job openings in Hyderabad for B Pharm / M Pharm candidates.
Clinical trials quality assurance (QA) refers to the systematic evaluation of the various processes and procedures involved in conducting clinical trials to ensure that they are in compliance with relevant regulations and guidelines. The goal of clinical trials QA is to ensure the integrity, reliability, and validity of the data collected during the trial, as well as the safety and welfare of the trial participants.
Clinical trials QA is an important aspect of the overall clinical trial process, as it helps to ensure that the trial is conducted ethically and in accordance with good clinical practice (GCP). It is typically the responsibility of the sponsor or principal investigator of the trial to ensure that QA measures are in place and are followed throughout the trial. This may involve developing and implementing standard operating procedures (SOPs), conducting quality control checks, and performing audits to assess the quality of the trial data.
If you are interested in working in clinical trials QA, you may want to consider pursuing a degree in a field such as science, nursing, or healthcare administration, and gaining relevant experience through internships or entry-level positions. You may also want to consider obtaining certification through a professional organization such as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) or the Clinical Research Quality Association (CRQA).
- 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
Experience: 2-6 Years experience in CT QA or CT Operations
Qualification: B Pharm / M Pharm
Job type: Full-Time
Apply here: email@example.com
For more information and job description, please visit https://www.advityresearch.com/careers