Clinical Research Associate

Clinical Research Associate BEC #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Job Summary Responsible for study management and execution of studies as per the established Standard Operating Procedures SOP, Good Clinical Practices GCP, Good Laboratory Practices GLP best practices and regulatory requirements Job Responsibilities Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures. Assists with Protocol, ICF writing, Case Report and Assists with the preparation of screening and study documentation for data collection Assists with followup appointments of Subjects Assists as required in the receipt, dispensation and inventory of test articles Prepares the clinic for study conduct ensuring all furniture, supplies and equipment ready for screeningclinic activities Ensures clinic staff activities for compliance with protocol and SOPs Assists with the Collection, reviewing and summarizing of clinical data and compilation of the clinical report Assist with the distribution of test articles to subjects as delegated by the Study Coordinator Conducts activities related to the transfer of subject samples Responsible for initiation and completion of archival of clinic study raw data, documents and records. Executes other duties as may be assigned by the Clinical Operations Managementdelegate as training and experience allow. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned. Job Requirements BScMSc B. Pharmacy M. Pharmacy 12 years experience Preferable