Clinical Research Associate

Sun Pharma; Chennai District; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma is seeking a Clinical Research Associate to support site feasibility, select investigators, negotiate budgets, and finalize contracts across centers in Mumbai/Chennai.

You will oversee IP dispensing, inventory reconciliation, site initiation and monitoring, and ensure timely data entry and SAE reporting in compliance with GCP.

Qualifications

• Minimum qualification: Bachelor's or Master's degree in health-related field such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research.

Responsibilities

• Perform site feasibility, identify investigators, negotiate budgets, finalize investigators/sites, and execute study-related contracts.
• Prepare and submit study documents for EC permission across centers.
• Oversee IP dispensing, inventory management & reconciliation.
• Ensure timely site initiation, monitoring, and close-out activities with reports.
• Provide investigator and site personnel training on study protocol, procedures, and GCP.
• Ensure timely recruitment, data entry, source data verification, and query resolution.
• Report SAEs/SUSARs per PV policies; align with regulations.
• Coordinate with in-house/CROs for data management and analyses.

Skills

Clinical Research

Education

Bachelor's or Master's in health-related field

Job description

Job Title: Clinical Research Associate

Business Unit: Medical Affairs & Clinical Research

Location: Mumbai / Chennai

At Sun Pharma, we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys.

YOUR TASKS AND RESPONSIBILITIES:

• Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
• Preparation and submission of study documents for EC permission for respective study across centers
• Oversee & document IP dispensing, inventory management & reconciliation
• Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
• Investigator and site personnel training on the Study protocol, procedures, and GCP principles
• Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
• Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
• Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
• Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL

Job Requirements

Educational Qualification

Minimum qualification requirement is to have a Bachelors or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research

Experience

Relevant experience of 1-5 years minimum in the field of Clinical Research

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).