Clinical Research Associate – Dr. Reddy’s Laboratories
Organization: Dr. Reddy’s Laboratories Ltd.
Location: Hyderabad
Salary: Competitive
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories Ltd. is a leading global pharmaceutical company, recognized for delivering affordable and innovative medicines to patients worldwide. With over 24,000 employees in 66 countries, the company is committed to improving global healthcare. By 2030, Dr. Reddy’s aims to provide healthcare solutions to over 1.5 billion patients.
For more information on pharmaceuticals, check out Wikipedia.
Position Overview
As a Clinical Research Associate (CRA), you will play a critical role in overseeing clinical investigational site activities. Your main focus will be ensuring compliance with Good Clinical Practices (GCP), regulatory requirements, and clinical trial protocols. From feasibility assessments to site management, you will be involved in the entire clinical trial process.
Key Responsibilities
- Study Start-up: Facilitate the initiation of clinical trials at investigational sites.
- Site Feasibility: Conduct assessments to ensure the site’s capability to conduct the trial.
- Documentation: Collect and manage essential documents for regulatory submissions.
- Training: Provide training to site staff on clinical trial protocols.
- Data Management: Ensure accurate and timely data collection, entry, and reporting.
- Monitoring: Perform investigational product (IP) accountability and monitoring at clinical sites.
- Compliance: Ensure adherence to protocol, ICH-GCP guidelines, and applicable regulations.
- Audit Support: Maintain the Trial Master File (TMF) for audit readiness.
- Contract Management: Coordinate site payments and handle contract negotiations.
For more on Good Clinical Practices (GCP), refer to Wikipedia.
Qualifications
| Qualification | Details |
|---|---|
| Degree | Master’s in Pharmacy, Life Sciences, Biology, Biotechnology, Biochemistry, or Clinical Research |
| Experience | 2-5 years of experience in clinical trial operations |
| Skills | Knowledge of GCP and ICH guidelines, proficiency in EDC systems, project management |
- GCP Knowledge: Strong understanding of Good Clinical Practice and ICH guidelines.
- Data Management: Proficiency in Electronic Data Capture (EDC) systems.
- Communication: Excellent project management and communication skills.
- Independence: Ability to work autonomously and manage multiple sites.
More information on ICH guidelines can be found on Wikipedia.
Benefits
- Competitive Salary: Attractive compensation and benefits package.
- Learning & Development: Personalized training programs tailored to your career growth.
- Medical Coverage: Comprehensive health benefits for you and your family.
- Relocation Support: Assistance for relocating and family support programs like maternity/paternity leave.
Why Join Us?
At Dr. Reddy’s, we believe in fostering innovation, sustainability, and global healthcare solutions. You will be a part of a dynamic team that values scientific rigor and aims to make a difference in the world. We offer an environment that promotes personal and professional growth, with opportunities to advance in the field of clinical research.
Call to Action
Ready to contribute to a brighter future in healthcare? Apply now to be a Clinical Research Associate at Dr. Reddy’s Laboratories!
Visit our website for more information and to submit your application.