Clinical Research Associate – Join Sun Pharma and Advance Medical Innovation!
Summary:
Sun Pharma Laboratories Ltd, a leading pharmaceutical company in India, is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team in Hyderabad. This is an exceptional opportunity to contribute to groundbreaking clinical trials, ensuring ethical conduct and adherence to Good Clinical Practice (GCP) standards. If you’re passionate about clinical research operations, site management, and building a career with a global leader, we encourage you to apply!
About Sun Pharma
Sun Pharma is committed to improving global healthcare through innovation, quality, and a dedication to patient well-being. As India’s largest pharmaceutical company with a significant presence in over 100 countries, we focus on transforming healthcare delivery and fostering a supportive, growth-oriented environment for our employees. At Sun Pharma, we believe in empowering individuals to “Create Your Own Sunshine” by providing opportunities for continuous learning and professional development.
Job Description
As a Clinical Research Associate, you will play a vital role in the execution of clinical trials, ensuring the integrity of data and the well-being of participants. You will be responsible for the comprehensive management of clinical trial sites, from initiation to close-out, working closely with investigators and other stakeholders.
Key Responsibilities:
- Site Management:
- Conduct thorough site feasibility assessments to identify potential investigators and assess site capabilities.
- Negotiate study budgets with potential sites, ensuring fair and accurate compensation for their participation.
- Finalize investigator and site contracts, including Confidential Disclosure Agreements (CDAs) and study agreements, in compliance with company policies and legal requirements.
- Regulatory Compliance:
- Coordinate and manage study submissions to Ethics Committees (ECs) to obtain necessary approvals for clinical trial conduct.
- Ensure all activities are conducted in accordance with ICH-GCP guidelines and relevant Indian clinical trial regulations.
- Investigational Product Management:
- Oversee the dispensing, inventory management, and reconciliation of Investigational Product (IP) at clinical sites.
- Maintain accurate records of IP accountability and ensure proper storage conditions.
- Monitoring and Training:
- Conduct site initiation, monitoring, and close-out visits, documenting all activities in detailed and accurate monitoring reports.
- Train investigators and site personnel on study protocol, GCP guidelines, and Standard Operating Procedures (SOPs).
- Data Integrity and Safety:
- Monitor subject recruitment and enrollment to ensure adequate participation in the study.
- Oversee data entry, perform source data verification, and resolve data queries in a timely and efficient manner.
- Ensure timely and accurate reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in accordance with regulatory and pharmacovigilance policies.
- Risk Management and Collaboration:
- Identify and mitigate site-related risks through the implementation of Corrective and Preventative Actions (CAPA).
- Collaborate effectively with Contract Research Organizations (CROs), data management teams, and biostatistics teams to ensure timely data analysis and reporting.
Qualifications and Experience:
- Education:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biology, Chemistry, Nursing, or Public Health.
- A Post-Graduate Diploma in Clinical Research is preferred.
- Experience:
- Minimum 1–5 years of experience in clinical research, particularly in Phase III/IV trials.
- Core Competencies:
- In-depth knowledge of ICH-GCP guidelines and Indian clinical trial regulations.
- Strong site management and stakeholder coordination skills.
- Excellent written and verbal communication skills.
- Exceptional attention to detail and a strong commitment to compliance.
Why Join Sun Pharma?
At Sun Pharma, we offer a dynamic and rewarding work environment where your contributions are valued and recognized. We are committed to the professional growth and development of our employees, providing opportunities to expand your skills and knowledge in the field of clinical research.
Employee Benefits Include:
- Competitive salary and performance-based incentives.
- Continuous professional development programs and training opportunities.
- A collaborative, inclusive, and teamwork-driven environment.
- Exposure to global research operations and advanced clinical practices.
How to Apply
If you are a highly motivated individual with a passion for clinical research and a desire to contribute to improving patient outcomes, we encourage you to apply.
To apply for this exciting opportunity, please submit your application through our online careers portal. We look forward to hearing from you!