Clinical Research Associate - Chennai

Sun Pharma; Chennai District; On-site; INR 400,000 - 800,000; Full time

Job summary

Sun Pharma seeks a Clinical Research Associate to manage site feasibility, investigator selection, and contract execution across centers in Mumbai and Chennai. The role involves budget negotiation, IP handling, and ensuring GCP-compliant data collection and reporting.

The successful candidate will oversee EC submissions, training of site staff, SAE reporting, and CAPA implementation, contributing to study success within a collaborative medical affairs ecosystem.

Qualifications

• Bachelor's or Master's degree in biology, chemistry, nursing, pharmacy, or public health or postgraduate diploma in clinical research
• 1-5 years of clinical research experience preferred

Responsibilities

• Perform site feasibility and identify potential investigators
• Negotiate study budget and finalize investigators, sites, and contracts
• Prepare and submit study documents for EC permission across centers
• Oversee IP dispensing, inventory management and reconciliation
• Ensure timely site initiation, monitoring, and close-out activities with reports
• Train investigators and site personnel on protocol and GCP
• Ensure recruitment, data entry, SDV, and query resolution are timely
• Report SAEs/SUSARs per regulations and PV policies
• Identify risks and implement CAPA for underperforming sites
• Coordinate with CROs for data management and statistics reports

Skills

Site feasibility

Budget negotiation

GCP compliance

Regulatory documentation

Training investigators

Data entry & query resolution

SAE/SUSAR reporting

CAPA & risk assessment

Education

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

Post-graduate Diploma in Clinical Research

Tools

EC submission

Job description

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 Bachelor's 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).