This role includes reviewing and assessing clinical trial protocols, study documentation, and processes to ensure compliance with regulatory requirements, internal quality standards, and Valuable Clinical Practice (GCP).

The Senior

Associate will collaborate with Clinical Research Associates, project managers, and clinical operations teams to conduct quality reviews, support audits, and track corrective and preventive actions. Day-to-day responsibilities include monitoring quality metrics, assisting in the development and maintenance of SOPs, supporting training initiatives on quality and compliance, and contributing to risk assessments and process improvements. The role also involves working closely with cross-functional stakeholders to maintain data integrity, ensure inspection readiness, and support continuous enhancement of clinical research quality systems.

Qualifications

- Candidates should possess strong knowledge of clinical trial protocols and regulatory guidelines, including GCP and applicable international standards.




- Candidates should possess experience working with Clinical Research Associates and cross-functional clinical teams to support quality oversight and compliance.
- Candidates should possess hands-on experience in clinical trials and clinical research, including familiarity with study start-up, conduct, and close-out activities.
- Candidates should possess understanding of clinical operations processes and quality management practices within global clinical development.
- Relevant experience in quality assurance within clinical research or pharmaceuticals, including participation in audits and inspections.
- Strong analytical, documentation, and problem-solving skills, with attention to detail and ability to interpret complex regulatory requirements.
- Excellent written and verbal communication skills, with the ability to work effectively in a remote, cross-cultural, and cross-functional environment.

📌 Senior Associate, Quality Assurance - Clinical research (India)
🏢 Intrinseque Health
📍 India