We are currently seeking a Senior Clinical Research Associate to join our growing team. In the role you will be responsible for:

• Working in accordance with ICH E6 principles and with applicable SOPs
• Accompanied visit as a part of mentoring a new CRA
• Conduct of Feasibility assessments
• Project set up activities
• Conduct of site selection activities
• Negotiation and facilitating Investigator/site contract execution
• Development and local adaption of study specific documentation
• Set up of the trial master file
• Project conduct
• Maintenance of TMF
• Facilitating Regulatory submission
• Prepare, conduct and participate in Investigator’s meeting
• Conduct Site initiation and site monitoring
• Maintain communication with study teams at site
• Maintain communication with clients and vendors as back-up for a project manager/project team lead
• Resolution of site level issues and where necessary escalation of issues to PM
• Support PM/PTL with project updates
• Participate in client meetings/teleconferences and inter-departmental meetings
• Support in vendor selection, agreement and co-ordination
• CRF retrieval and Query turnaround
• Facilitate site payments
• Project closeout
• Reconciliation and archival/disposal of study documentation
• Reconciliation and disposal/destruction of Investigational products
• Conduct site closeout visits
• Training: Participate/conduct training periodically as assigned by the project manager
• Participation in other department initiatives/activities

• Clinical Trial Monitoring Onsite in Phase II-IV studies
• Experience in working in Multiple Indications and good understanding level
• Good working knowledge of Microsoft Office including Word, PowerPoint, and Excel
• Good understanding of GCP and Indian Regulatory