Clinical Trials

5 days ago


Chennai, India Seven Consultancy Full time

Job Description - Creating and writing trial protocols and presenting them to the steering committee. - Identifying, evaluating, and establishing trial sites, and closing sites after trial completion. - Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. - Liaising with ethics committees regarding the rights, safety, and well-being of trial subjects. - Ordering, tracking, and managing investigational products (IP) and trial materials. - Overseeing and documenting IP dispensing, inventory, and reconciliation. - Protecting subject confidentiality, updating their information, and verifying IP administration according to protocol. - Conducting regular site visits, coordinating project meetings, and preparing visit reports. - Implementing corrective action plans for underperforming sites. - Liaising with regulatory authorities as required. - Ensuring compliance with SOPs, local regulations, ICH, and GCP guidelines. - Performing other clinical research tasks and responsibilities as assigned.



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    4 hours ago


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