Job Title: Clinical Research Associate
Location: Hyderabad, Corporate Office
About Sun Pharma:
Sun Pharma is a leading global pharmaceutical company committed to innovation and improving lives. We foster a collaborative environment where employees can grow, take ownership, and continuously learn. We believe in empowering our employees to “Create your own sunshine” by providing them with challenging opportunities and a supportive work culture.
Job Summary:
Sun Pharma Laboratories Ltd is seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team in Hyderabad. This exciting opportunity is ideal for individuals looking to build or advance their careers in clinical trials, site management, GCP compliance, and clinical research operations. As a CRA, you will play a crucial role in the execution of Phase III & IV clinical trials, working with leading investigators across India.
Responsibilities:
As a Clinical Research Associate, you will be responsible for the following:
- Site Management:
- Conducting site feasibility assessments and identifying potential investigators.
- Negotiating study budgets with potential sites.
- Finalizing investigator sites and executing Confidential Disclosure Agreements (CDAs) and study contracts.
- Regulatory Compliance:
- Preparing and submitting required documents for Ethics Committee approval.
- Investigational Product Management:
- Managing the dispensing, inventory, and reconciliation of Investigational Product (IP) at study sites.
- Site Monitoring:
- Performing site initiation, monitoring, and close-out visits in accordance with the study protocol and relevant regulations.
- Generating detailed and accurate monitoring visit reports.
- Training & Support:
- Training investigators and site teams on study protocols, Good Clinical Practice (GCP) requirements, and other relevant guidelines.
- Data Management & Recruitment:
- Ensuring timely patient recruitment and enrollment at study sites.
- Performing source data verification (SDV) to ensure data accuracy and integrity.
- Managing and resolving data queries in a timely manner.
- Safety Reporting:
- Managing Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting in accordance with regulatory and pharmacovigilance (PV) guidelines.
- Risk Management & Problem Solving:
- Identifying potential risks at study sites and implementing proactive mitigation strategies.
- Performing root-cause analysis for identified issues and implementing Corrective and Preventive Actions (CAPA).
- Collaboration & Coordination:
- Coordinating with internal teams and Contract Research Organizations (CROs) for data management, statistical analysis, and other study-related activities.
Qualifications:
- Bachelor’s or Master’s degree in one of the following disciplines:
- Pharmacy
- Nursing
- Biology
- Chemistry
- Public Health
- OR a Post-Graduate Diploma in Clinical Research.
Experience:
- 1 to 5 years of relevant experience in clinical research.
- Hands-on experience in Phase III and Phase IV clinical trials is essential.
- Strong knowledge of ICH-GCP guidelines, New Drugs and Clinical Trials (NDCT) Rules, and other relevant regulatory guidelines.
- Proven expertise in site management and coordination across multiple sites.
Key Skills:
- Proficient in site monitoring and documentation.
- Comprehensive understanding of clinical trial regulations and guidelines.
- Strong knowledge of GCP principles and protocol compliance.
- Excellent cross-functional collaboration skills.
- Ability to identify risks and implement effective CAPA plans.
- Exceptional written and verbal communication skills.
- Strong attention to detail and organizational skills.
Benefits of Working at Sun Pharma:
Sun Pharma is committed to fostering a supportive and rewarding work environment for its employees. We offer:
- A collaborative and supportive work culture.
- Comprehensive learning and development initiatives to enhance your skills and knowledge.
- Opportunities for career progression and advancement within the company.
- Exposure to innovative clinical research programs and cutting-edge technologies.
- Competitive compensation and benefits package.