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. 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.
