Working in Substation /33/11/LT/DTC Line erection and commissioning.

Operational responsibility Responsible for coordinating the planning, development, and implementation of clinical protocol, administrative and logistical procedure, documentation and operating system.Supervises, evaluates and coordinates the study team activities, ensures that all clinical activities are carried out in accordance with GCP, established SOPs and applicable regulations.Project Planning, tracking of timelines and project development and delivery as assigned.Define, review and approve project tracking tools, budget and training requirement.Development of plan and strategies for recruitment and retention of subjects.Development of project specific communication plan including an escalation process for fraud, misconduct and SAE etc.Co-ordinates regulatory process.Preparation of confidential Agreement, Clinical Trial Agreement.Budget negotiation and finalization with sponsor.Budget negotiation and finalization with Investigator.Ensures ongoing status update sent to sponsor.Review and approval of monitoring reports, Site regulatory package documents and Trial master file.Investigator meeting planning and conduction.Development of quality plan to ensure good data quality. Managerial responsibilitiesAssessment of operational, financial and material requirements for the study.Preparation of operating budgets, planning and coordination of procurement of required clinical facilities, equipment and supplies.Selection and coordination with out side agencies and vendors.Planning, scheduling and oversees of day-to-day activities of the study team.Representation and promotion of the objectives and activities of research studies to various internal and external stakeholders, as necessary.

Operational responsibility Responsible for all clinical study related activities in-house & at the site.Responsible for the quality of the clinical project by assuring adherence to GCP, Schedule Y, compliance with the protocol and all project related procedures & SOP’s Management of clinical study setup and follow up study activities as per the Study plan. Co-monitoring/accompanied site visits to train the team members. Identification of quality issues during the study through regular review of the clinical team communications including site communications.Local Vendor management, negotiation and Finalization of their budget Review & finalization of Clinical Trial Agreement and site specific budget Review of regulatory and administrative documents from investigator sitesInvestigators’ Meetings Planning and coordination. Responsible for planning and tracking the conduct of the study in compliance with the study budget and quality standards and timelines Job Responsibilities Identification of potential sites and InvestigatorsFeasibility Assessment & Site selection Investigators Meeting CoordinationEthics Committee submission , CTRI registrationCollection & review of regulatory documentsSite-specific budget preparation and negotiation.Coordination with Translation agencies Site Initiation & trainingSite Monitoring and Source Data VerificationDrug accountabilityQuery resolutionStudy document ArchivalSite Close out