Overall responsibility for study management, responsible for monitoring of studies in accordance to protocol/ SOPs/ Guidelines.
Perform Site Identification and conduct Feasibility Studies. Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines. Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines. Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required. Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities. Act as a communication Link between Sponsor and the site. Maintain accurate and timely sponsor/site correspondence and communication. Attend Investigators Meeting. Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines. Ethics Committee Submission Help in preparation of Regulatory Binder. Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File. CRF retrieval as per the project instructions. Coordinate and distribute Clinical Study Material to study sites. Archival of study documents.
Resolve GROUP OF COMPANIES Resolve is a leading global research organization providing comprehensive, integrated drug development, laboratory management services. Our clients and partners include pharmaceutical, biotechnology, medical device, and academic and government organizations. Resolve applies innovative research, therapeutic expertise and a firm commitment to Pharma companies and time curve of drug development and optimize value in delivering life-changing therapies, drugs to improve health.
Job Description :
To ensure customer service and support all operations. To create customer delight at every interaction.
Interacting with external customers and internal customers and addressing their queries, requests and complaints.
Committed TATs are met consistently
Complaints Management- addressing customer complaints at the branch, system updation, coordination with Sales/HUB/ other functions for resolution.
Refunds processing and dispatch
Undelivered policy documents tracking and management.
Maintenance of all files and registers.
New Business Processing:-
Handling end to end New business processing starting from creation of Client id,Case start up, New business login, Follow up for policy issuance, Quality Check
Follow up with HUB for policy issuance of pending cases