Clinical Research Associate Position at Dr. Reddy’s Laboratories- Apply before 25th March 2025

Dr. Reddy’s Laboratories
📍 Location: Hyderabad, India
📅 Application Deadline: 25th March 2025

About Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company committed to accelerating access to affordable and innovative medicines. Founded in 1984, we have expanded our presence to 66 countries with a workforce of over 24,000 professionals. Our mission, Good Health Can’t Wait, drives us to develop high-quality pharmaceuticals and cutting-edge research solutions.

Job Summary

We are seeking an experienced Clinical Research Associate to support clinical trial operations. The ideal candidate will be responsible for coordinating clinical site activities, ensuring compliance with protocols, and facilitating data collection to drive research excellence.

Key Responsibilities

Study Start-up & Site Management

• Conduct feasibility assessments and qualification visits for clinical sites.
• Assist in collecting essential regulatory documents and site validation records.
• Coordinate clinical trial material supply before study initiation.
• Train site personnel on protocols and compliance requirements.

Clinical Trial Monitoring & Compliance

• Oversee site operations, ensuring adherence to study protocols and regulatory guidelines.
• Conduct source data verification (SDV) and review informed consent forms.
• Manage clinical trial records, including case report forms (CRFs) and safety data.
• Identify and mitigate deviations, ensuring adherence to ICH-GCP and Good Documentation Practices (ALCOA-C).

Investigational Product (IP) Management

• Monitor the supply, storage, and administration of investigational products.
• Oversee IP reconciliation, including documentation of shipments, usage, and destruction.

Site Contracts & Financial Coordination

• Support site contracting processes, including confidentiality agreements and clinical trial agreements.
• Ensure site payments align with trial milestones and monitor invoice approvals.
• Coordinate with vendors and internal teams to resolve site-related queries.

Trial Master File (TMF) & Inspection Readiness

• Maintain up-to-date investigator site files and regulatory documents.
• Conduct periodic reviews of onsite and central trial documentation.
• Assist in audits and inspections, ensuring compliance with quality and regulatory standards.

Candidate Profile

Education & Experience

🎓 Qualifications:

• Master’s degree in Pharmacy, Life Sciences, Biology, Biotechnology, Biochemistry, or a Diploma in Clinical Research.
• Experience: 2 – 5 years in clinical research or trial management.

Technical Skills

• Proficiency in clinical trial operations, regulatory compliance (GCP, ICH guidelines), and pharmacovigilance.
• Familiarity with Electronic Data Capture (EDC) systems for clinical trial data management.
• Strong understanding of market research and medical terminology.

Behavioral Skills

✔ Strong communication, negotiation, and project management abilities.
✔ Excellent problem-solving skills and keen attention to detail.
✔ Results-driven with a passion for research and healthcare innovation.

Why Join Us?

• Work with a globally recognized pharmaceutical leader.
• Contribute to cutting-edge clinical research that impacts global healthcare.
• Be part of a dynamic and innovation-driven team.

📌 Industry: Pharmaceuticals, Healthcare, Clinical Research
📌 Functional Area: Clinical Operations

Ready to take the next step in your clinical research career? Apply now! 🚀