Clinical Compliance Associate

Desired Candidate Profile:

• Strong knowledge and skill in applying all applicable clinical research regulatory requirements; i.e., International Conference on Harmonization (ICH) GCP & CDSCO guidelines.
• Experience in hoisting any regulatory inspection at a clinical site is an advantage.
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication skills including good command over English language.
• Strong organizational and problem-solving skills.
• Open for travelling (40% of travel involved)
• Effective time management skills

Responsibilities:

1. Ensure availability of essential documents for a clinical study prior to study initiation.

2. Conduct GCP compliance audits at clinical sites to ensure:

I. Investigator & site staff qualification & experience

II. Adequacy of resources

III. Adequacy of written procedures or instructions at site

IV. Subject safety

V. Data reliability

VI. Consistency and compliance in data collection process and records maintenace

VII. e-CRF completion and consistency with source documents

VIII. Investigational drug supply and accountability

3. Review the Trial Master File to ensure accuracy and completeness of the documentation in sync with the Site Master File.

4. Review the clinical study report to ensure compliance with relevant standards/regulations and consistency with data generated during the study.

5. Support process improvements and review of procedures (SOP) updates as needed.

6. To support the preparation, conduct and response to internal and external audits/regulatory inspections.