Sr. Associate/ Team Lead- Clinical Research:

Overview of the role

• Lead clinical studies to ensure that study is conducted in compliance with the protocol, Sponsors SOPs, Good Clinical Practice (GCP) and relevant regulatory guidelines
• Perform following monitoring activities directly or mange through SMO/ CRO
• Perform/ Review/ Oversee Site Identification and conduct Feasibility Studies, Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit 
• Ensure Follow Up letters to sites are sent and submit Visit Reports to the Clinical Project Manager as required 
• Training of study team/ clinical sites on Protocol and other applicable regulatory guidelines including local regulatory guidelines 
• Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities along with internal stakeholders 
• Ensure timely Ethics Committee Submission by sites .
• Ensure subject safety and adverse event reporting to sponsor and IRB/IEC