Clinical Research Associate at Sun Pharma
- Position Name: Clinical Research Associate
- Company Name: Sun Pharma Laboratories Ltd.
- Department: Clinical Research
- Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
- Experience: 4-5 years
- Salary: ₹45,000 – ₹65,000 per month
- Job Location: Mumbai
About Sun Pharma
Sun Pharma Laboratories Ltd. is one of India’s leading pharmaceutical companies, renowned for its innovation and commitment to quality. The company is involved in a broad spectrum of pharmaceutical research and development, including clinical trials that contribute to global healthcare solutions.
Position Overview
Sun Pharma is seeking a highly qualified Clinical Research Associate (CRA) to join our team at the Sun House Corporate Office in Mumbai. The CRA will play a critical role in managing and overseeing clinical trials, ensuring that all aspects of the trials are conducted in compliance with regulatory standards and company policies.
Key Responsibilities
As a Clinical Research Associate, your duties will include:
Study Preparation & Execution
- Site Feasibility & Investigator Identification:
- Conduct site feasibility studies and identify potential investigators.
- Develop and manage study budgets.
- Finalizing Study Logistics:
- Finalize investigators and study sites.
- Execute Confidential Disclosure Agreements (CDAs) and manage study-related contracts.
- Plan and conduct Investigator Meetings as needed.
- Ethics Committee (EC) Approval:
- Prepare and submit study documents for EC approval, ensuring adherence to ethical standards.
Site Management
- Trial Supply Logistics:
- Facilitate the procurement of Investigational Products (IP) and ensure smooth logistics.
- Site Monitoring:
- Perform site initiation, monitoring, and close-out activities.
- Oversee IP dispensing, inventory management, and reconciliation.
- Training:
- Train investigators and site personnel on study protocols, procedures, and Good Clinical Practice (GCP) principles.
Data Management & Compliance
- Participant Recruitment:
- Ensure efficient recruitment of trial participants and effective data management.
- Site Monitoring Visits:
- Conduct regular monitoring visits to review source data, informed consent forms, and case report forms for accuracy and compliance.
- Safety Reporting:
- Ensure timely reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and adherence to regulatory and company Pharmacovigilance (PV) policies.
Coordination & Reporting
- Project Meetings:
- Coordinate project meetings and prepare monitoring visit reports.
- Budget Management:
- Manage trial budgets and maintain accurate financial accounts.
- CRO Coordination:
- Coordinate with Contract Research Organization (CRO) partners for data management and statistical analysis.
- Data Query Resolution:
- Lead and guide the resolution of data queries.
Risk & Quality Management
- Risk Identification & Mitigation:
- Identify risks, analyze them, and implement Corrective and Preventive Actions (CAPAs) for sites not meeting expectations.
- Audit Handling:
- Effectively handle audits and inspections to ensure trial quality and compliance.
Qualifications
To excel in this role, you should possess:
Experience
- Years of Experience:
- 4-5 years in clinical operations within a CRO, pharmaceutical, or biotech environment, particularly handling large multi-site clinical trials.
Skills & Knowledge
- GCP & Regulatory Knowledge:
- In-depth knowledge of Good Clinical Practice (GCP) guidelines, Indian Council of Medical Research (ICMR) guidelines 2017, and the Drugs and Cosmetics Act.
- Clinical Trial Methodologies:
- Proficiency in clinical trial methodologies, research design, and remote/risk-based monitoring.
- Research & Analytical Skills:
- Strong research and analytical skills, with the ability to interpret complex data.
Competencies
- Integrity & Strategic Thinking:
- Integrity in decision-making, strategic thinking, and a results-oriented mindset.
- Communication Skills:
- Excellent interpersonal and communication skills, with the ability to work effectively in a matrix environment.
Working Conditions
- Travel Requirements:
- The role is primarily office-based but requires an average of 8 to 10 days of travel outside the office each month.
Compensation
- Salary Range:
- ₹45,000 – ₹65,000 per month
Application Process
If you meet the qualifications and are interested in making a significant contribution to clinical research at Sun Pharma, we encourage you to apply. Join our team and help advance global healthcare through rigorous clinical trials and innovative research.