Clinical Research Associate (Clinical Trials)
Location: Hyderabad, India
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Date Posted: February 13, 2026
Employment Type: Full-Time
ThePharmaDaily.com is featuring an opportunity for a Clinical Research Associate (CRA) to join the Clinical Research division of Sun Pharma Laboratories Ltd. This role is ideal for professionals with hands-on experience in Phase III and Phase IV clinical trials, site management, and regulatory compliance within the pharmaceutical industry.
Role Overview
The Clinical Research Associate will be responsible for end-to-end site management activities across multicenter clinical trials. The role includes feasibility assessment, ethics submissions, monitoring visits, investigational product management, safety reporting oversight, and coordination with CRO and internal cross-functional teams.
This position plays a critical role in ensuring regulatory compliance, data integrity, patient safety, and timely clinical trial execution in alignment with ICH-GCP and applicable regulatory requirements.
Key Responsibilities
Study Start-Up & Site Feasibility
Conduct site feasibility assessments and identify potential investigators.
Negotiate study budgets and finalize investigator/site selection.
Execute Confidentiality Disclosure Agreements (CDA) and study-related contracts.
Prepare and submit study documents for Ethics Committee (EC) approvals across study centers.
Clinical Trial Monitoring & Site Management
Ensure timely site initiation, routine monitoring, and close-out visits.
Generate and maintain monitoring visit reports and essential documentation.
Oversee Investigational Product (IP) dispensing, inventory management, and reconciliation.
Train investigators and site staff on protocol procedures and GCP principles.
Ensure participant recruitment targets are met and data entry timelines are maintained.
Perform Source Data Verification (SDV) and manage query resolution.
Safety & Regulatory Compliance
Ensure timely reporting of SAEs and SUSARs in compliance with regulatory requirements and pharmacovigilance policies.
Communicate safety updates to sites and investigators.
Identify site-related risks and implement Corrective and Preventive Actions (CAPA).
Cross-Functional Coordination
Coordinate with in-house teams and CRO partners for:
Data management
Statistical analysis
Statistical analysis reports
Database lock (DBL)
Collaborate with regulatory, pharmacovigilance, and medical teams to ensure seamless trial execution.
Experience Required
1–5 years of relevant experience in Clinical Research within pharmaceutical companies or CRO environments.
Hands-on experience in Phase III and Phase IV clinical trials.
Proven experience in site management, monitoring visits, and regulatory documentation.
Experience managing safety reporting and investigator communications preferred.
Educational Qualification
Bachelor’s or Master’s degree in Biology, Pharmacy, Nursing, Chemistry, Public Health, or related health sciences.
Postgraduate Diploma in Clinical Research preferred.
Core Competencies & Skills
Strong knowledge of ICH-GCP guidelines and clinical trial regulatory frameworks.
Expertise in site monitoring and investigator management.
Understanding of safety reporting processes (SAE/SUSAR).
Strong organizational and documentation skills.
Ability to collaborate with cross-functional stakeholders.
Excellent communication and analytical skills.
Proactive risk identification and problem-solving capabilities.
Why This Role Is Strategic
This position contributes directly to the successful execution of pivotal clinical trials and supports regulatory submissions and product lifecycle development. It offers structured career progression in Clinical Operations, Regulatory Affairs, and Global Trial Management within one of India’s leading pharmaceutical organizations.
For professionals seeking to strengthen their expertise in clinical monitoring, regulatory compliance, and site management, this opportunity provides a strong platform for growth.
Explore more Clinical Research, Pharmacovigilance, Regulatory Affairs, and Global Clinical Operations roles on ThePharmaDaily.com – your trusted global pharmaceutical career platform.
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