Clinical Research Associate

Job Title Clinical Research Associate Business Unit Clinical Research Location Mumbai 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 2-5 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. 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). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. #J-18808-Ljbffr