Sun Pharma Laboratories Ltd is inviting applications for the position of Clinical Research Associate (CRA) in the Clinical Research Business Unit at its Hyderabad location. This opportunity is ideal for professionals with 1–5 years of clinical research experience who want to work in a globally recognized pharmaceutical company.
The Clinical Research Associate job at Sun Pharma focuses on managing clinical trial sites, ensuring regulatory compliance, monitoring study progress, and supporting investigators across Phase III and Phase IV clinical trials. Candidates with strong knowledge of Good Clinical Practice (GCP), regulatory guidelines, and clinical trial operations will find this role highly rewarding.
At Sun Pharma, employees are encouraged to “Create their own sunshine” by growing professionally, collaborating with industry experts, and contributing to innovative clinical research programs.
Key Responsibilities – Clinical Research Associate (CRA)
The Clinical Research Associate role at Sun Pharma involves multiple responsibilities related to clinical trial monitoring and site management.
Site Selection & Study Initiation
- Conduct site feasibility assessments and identify potential investigators.
- Negotiate study budgets with investigators and sites.
- Finalize clinical trial sites and execute Confidential Disclosure Agreements (CDA) and study contracts.
Regulatory & Ethics Submissions
- Prepare and submit clinical study documents for Ethics Committee (EC) approvals.
- Ensure regulatory compliance with ICH-GCP and applicable clinical trial regulations.
Clinical Trial Monitoring
- Perform site initiation visits, monitoring visits, and site close-out activities.
- Ensure documentation and clinical trial monitoring reports are generated on time.
Investigational Product Management
- Oversee Investigational Product (IP) dispensing, inventory management, and reconciliation at sites.
Investigator & Site Training
- Train investigators and site staff on study protocols, procedures, and GCP guidelines.
Patient Recruitment & Data Quality
- Monitor clinical trial participant recruitment and retention.
- Ensure source data verification (SDV), accurate data entry, and timely query resolution.
Safety Reporting
- Ensure timely reporting of SAEs and SUSARs.
- Coordinate safety communication between sites and investigators according to Sun Pharma pharmacovigilance policies.
Risk Management
- Identify risks at clinical trial sites and implement CAPA (Corrective and Preventive Actions) when necessary.
Cross-Functional Coordination
- Collaborate with data management teams, statisticians, CRO partners, and internal stakeholders to ensure smooth study execution and database lock.
Qualifications & Skills
Educational Qualification
Candidates should hold one of the following:
- Bachelor’s or Master’s degree in a health-related field such as:
- Pharmacy (B.Pharm / M.Pharm)
- Biology
- Chemistry
- Nursing
- Public Health
OR
- Post-Graduate Diploma in Clinical Research (PGDCR)
Experience
- 1–5 years of relevant experience in Clinical Research or Clinical Trials.
Required Skills
- Strong knowledge of ICH-GCP guidelines and clinical trial regulations.
- Experience in Phase III and Phase IV clinical trials.
- Expertise in site management and monitoring.
- Ability to collaborate with cross-functional teams and investigators.
- Strong documentation, communication, and regulatory compliance skills.
Why Join Sun Pharma?
Sun Pharma provides a supportive workplace designed to foster growth and innovation.
Benefits and Opportunities
- Work with India’s leading pharmaceutical company.
- Exposure to global clinical trials and regulatory frameworks.
- Professional growth through clinical research training and career development programs.
- Collaborative work culture focused on continuous improvement and innovation.
- Opportunity to contribute to drug development and patient safety worldwide.
How to Apply
