Trainee Research Associate (C)

Axisclinicals; La Traine de Nioron; On-site; EUR 45,000 - 65,000; Full time

Job summary

Axisclinicals is seeking a QA/regulatory auditor to support the lifecycle of SOPs, logs, and master lists, ensuring accuracy and compliance with regulatory requirements across studies.

You will review protocols, ICFs, audits of IRB/IEC, vendor services, and study reports; coordinate internal training; handle sponsor queries; and assist with eCTD packaging and regulatory submissions to strengthen compliance.

Responsibilities

• 1. Generation, distribution, retrieval, archival of SOPs and maintenance of related records/ log books/master list of SOPs.
• 2. Issue of controlled forms and log books for use.
• 3. Training of new employees by coordinating with different departments.
• 4. Conducting Facility and System audits.
• 5. Carry out periodic inspection and audit as per SOPs.
• 6. Conducting the audit of IRB/IEC/Vendor/Third party service provider.
• 7. Review of study protocols, Informed consent Forms (ICFs) in compliance to SOPs/regulatory requirements.
• 8. Carry out In process and retrospective audit of studies.
• 9. Compilation of documents/ eCTD preparation as per the regulatory requirement to support regulatory submission.
• 10. Review of rawdata, chromatograms and reports of bioanalytical method validations and studies in compliance to SOPs.
• 11. Review of Clinical, Bio statistical and Bioanaytical reports.
• 12. Review of software and equipment validations / IQ/OQ/PQ/Calibration documents.
• 13. Handling of regulatory/ sponsor queries and responses.

Job description

1. Generation, distribution, retrieval, archival of SOPs and maintenance of related records/ log books/master list of SOPs.

2. Issue of controlled forms and log books for use.

3. Training of new employees by coordinating with different departments.

4. Conducting Facility and System audits.

5. Carry out periodic inspection and audit as per SOPs.

6. Conducting the audit of IRB/IEC/Vendor/Third party service provider.

7. Review of study protocols, Informed consent Forms (ICFs) in compliance to SOPs/regulatory requirements.

8. Carry out In process and retrospective audit of studies.

9. Compilation of documents/ eCTD preparation as per the regulatory requirement to support regulatory submission.

10. Review of rawdata, chromatograms and reports of bioanalytical method validations and studies in compliance to SOPs.

11. Review of Clinical, Bio statistical and Bioanaytical reports.

12. Review of software and equipment validations / IQ/OQ/PQ/Calibration documents.

13. Handling of regulatory/ sponsor queries and responses.