Clinical Compliance Associate

Biological E; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Biological E is seeking a regulatory-compliant clinical research professional to ensure GCP/ CDSCO standards are met across studies. The role emphasizes documentation, audits, and effective cross-functional coordination.

You will lead GCP compliance audits, review Master Files, support SOP updates, and assist in regulatory inspections, with travel up to 40% and strong English communication.

Qualifications

• Experience with ICH GCP and CDSCO guidelines.
• Willingness to travel up to 40% of time.
• Strong written and verbal English communication.

Responsibilities

• Ensure availability of essential documents for a clinical study prior to initiation.
• Conduct GCP compliance audits at clinical sites covering staff qualifications, resources, procedures, subject safety, data reliability, and trial documentation.
• Review the Trial Master File and clinical study report for accuracy and regulatory alignment.
• Support SOP updates and process improvements; assist audits and regulatory inspections.

Skills

GCP knowledge

Regulatory compliance

Audit readiness

Documentation

Communication skills

Tools

MS Word

Excel

PowerPoint

Job description

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.