Clinical Research Associate - Mumbai

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.”

Key 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