Clinical Research Associate

3 weeks ago

Kolkata West Bengal, India Sun Pharmaceutical Industries Full time

Job Title Clinical Research Associate Business Unit Clinical Research Location Kolkata 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 Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together 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

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