The Clinical Research Associate (CRA) position at Sun Pharma Laboratories Ltd, based at the Sun House Corporate Office, focuses on managing and overseeing clinical trials. This role involves a broad range of responsibilities from site feasibility and investigator identification to site monitoring and data management.
Key Responsibilities:
- Study Preparation & Execution:
- Conduct site feasibility, identify potential investigators, and develop study budgets.
- Finalize investigators and sites, execute CDAs, and manage study-related contracts.
- Plan and conduct Investigator Meetings if necessary.
- Prepare and submit study documents for Ethics Committee (EC) approval.
- Site Management:
- Facilitate IP procurement and ensure smooth trial supply logistics.
- Oversee and document IP dispensing, inventory management, and reconciliation.
- Perform site initiation, monitoring, and close-out activities.
- Train investigators and site personnel on study protocols, procedures, and GCP principles.
- Data Management & Compliance:
- Ensure efficient recruitment of trial participants and effective data management.
- Conduct regular site monitoring visits, review source data, informed consent forms, and case report forms for accuracy and compliance.
- Ensure timely reporting of SAEs, SUSARs, and compliance with regulatory and company PV policies.
- Coordination & Reporting:
- Coordinate project meetings and prepare monitoring visit reports.
- Manage trial budgets and maintain accounts.
- Coordinate with CRO partners for data management and statistical analysis.
- Lead and guide data query resolutions.
- Risk & Quality Management:
- Identify risks, analyze them, and implement CAPAs for sites not meeting expectations.
- Handle audits and inspections effectively.
Qualifications:
- Experience: Over 4-5 years in clinical operations within a CRO, Pharma, or Biotech environment, particularly handling large multi-site clinical trials.
- Skills & Knowledge:
- In-depth knowledge of GCP guidelines, ICMR guidelines 2017, and the Drugs and Cosmetics Act.
- Experience in remote and risk-based monitoring.
- Proficiency in clinical trial methodologies and research design.
- Strong research and analytical skills.
- Competencies:
- Integrity in decision-making, strategic thinking, collaboration, and a strong orientation towards results.
- Excellent interpersonal and communication skills, with the ability to work in a matrix environment.
Working Conditions:
- Travel: The role is primarily office-based but requires an average of 8 to 10 days of travel outside the office each month.
