Job Description

• Planning of project activities and study timelines based on project goal and sponsor's expectation;
• Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project;
• Develop the project management plan, monitoring plan etc as required for the study;
• Develop study specific tools/forms, study templates as required for the study;
• Develop and manage project budget;
• Order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period;
• Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc);
• Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval;
• Track study progress and ensure project is conducted according to the plan;
• Communicate to monitors new study information, study timelines and goals, study requirements. Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management);
• Submit the weekly project report to management (e.g. Project Director, Senior Management);
• Study site selection, initiation (SIV) and clinical monitoring;
• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience;
• Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations;
• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol, and requirements;
• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. xhyhwjd Maintain and update these documents in investigator files, trial master files;
• Finalize budget and obtain signed contract from site, prior to site initiation visit;
• Provide guidance and training to entry-level CRA/CRA I/CRA II in collaboration with Line Manager.

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