Website Sun Pharma Ltd
Post Name: Clinical Research Associate (Clinical Trials)
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Location: Hyderabad
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
Job Requirements:
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
