Clinical Research Associate (CRA) - Delhi ....h1

Clinical Research Associate (CRA) - Delhi 
St.Jude Medicals - Delhi, Delhi

Job Title: Clinical Research Associate  Job Reports to following Title: Clinical Manager  Work Location: Delhi Essential Functions:  • Overall management of assigned study centers • Pre-trial activities (EC submissions), Site Training, Site Initiation & Monitoring • Lead CRA for assigned projects  • Act as the main line of communication between the sponsor and the investigator • Responsible for the safety and proper conduct throughout the trial Other Duties:  • Medical writing: Protocol, CRF, study report, abstracts & manuscript writing • Trial Master file preparation and maintenance for assigned projects • Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout • Verifying that the investigator follows the approved protocol and all GCP procedures • Verifying that source data/documents and other trial records are accurate, complete, and maintained • Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs • Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator Accountability/Supervision: Describe the significant problem solving / decision making responsibilities. Describe the type and external of supervision received and exercised. Relationship: Describe contacts and purpose of relationships. Internal:  • Clinical team (Clinical Director, Clinical Manager and other CRA’s): Day to day work relationship • Support team (IT, Accounts, HR): as per requirements • Sales & marketing team: project specific training and KoL meetings External:  • Site Clinical department (Clinical coordinators): Day to day work relationship • CRO’s: Project specific discussions and management Equipment and Software: List the type of equipment the incumbent in this position is required to work with.  • Computer system with complete knowledge of Microsoft Office and clinical oracle software Working Conditions: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential function of this job. Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job. • CRA to have 50-60% travel for monitoring and site management Qualifications:  • Post graduate (Masters in Pharmacy or equivalent clinical research qualification) Describe the minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job. List any certificates and/or registration required. Required:  • Should have a minimum of 1 year experience in monitoring clinical studies with a reputed medical device/pharmaceutical company/CRO • Complete knowledge of ISO: 14155 (2011), GCP, Schedule Y, ICMR ethical guidance • Basic knowledge of Clinical oracle software, Electronic data capture and Microsoft office Desired:  • Medical writing skills: Development of Protocol, CRF, study report, abstracts & manuscript writing Thanks & Regards Soumya