![]() ![]() ![]() Independently prepare and perform Investigator site visits relevant to the phase of the study including, site selection and qualification, initiation, regular monitoring or site closure visits as specified in the Project Plan and the Monitoring Guidelines.Collaborate closely with the entire study team, including the medical Monitor, Project Manager, and the entire in-house study team to ensure the successful execution of the clinical study.Monitor and provide site management oversight for assigned clinical trials (phase I- IV) according to ICH-GCP guidelines, FDA regulations, protocol and sponsor SOPs.Responsible for the start-up, initiation, implementation and the management of clinical trials for the assigned sites.Worked as an integral team member with respect to quality, integrity, timeliness, and cost effectiveness when monitoring Worked in conjunction with the in-house project teams to ensure that sites have adequate study drugs and supplies.Participate in various sponsor/project team communication and training sessions Prepares for and attends Investigator Meetings Responsible for the evaluation of clinical data to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH/GCP Guidelines.Ensure Visit Reports are written and submitted via CTMS within 5 working days of visit. ![]() Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.Developed recruitment strategies and an enrollment plan with the investigator and site staff to meet recruitment goals in coordination with the SOP and GCP guidelines.Coordinated with investigators and site workers to ensure that the protocol is being adhered to while checking for Protocol deviations throughout the course of the study. ![]()
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