job title: Clinical Research Associatte (Sunpharma)

Roles and Responsibilities

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

Educational Qualification

Bachelor's or Masters degree in a health or 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.

Additional Skills:

• Knowledge on GCP practices, regulatory guidelines in Clinical Trials

• Phase III and Phase IV Clinical Trials knowledge expertise

• Site Management expertise

• Collaboration with cross functional stakeholders