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.
Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly.
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