Study Nurse 研究護理師 (台北地區)

Brief Position Description: The Study Nurse is responsible for planning, directing, and managing clinical trials at site. The Study Nurse also implements remote site management activities according to the Site Management Plan, ensuring that clinical trials are conducted and documented, as per protocol, ICH GCP guidelines and applicable regulatory requirements and SOPs. Reporting to: As indicated on current organisation chart. Responsibilities: Conduct and complete remote site management activities and/or on-site visits according to the Site Management Plan. Specific duties include: Serve as a primary point of contact for site communication. Implement study start-up activities including but not limited to gathering feasibility information, negotiation of contract and budgets, planning for subject recruitment, communication with IRB/IEC. Collaborate with the principal investigator to prepare IRB/IEC and any other regulatory submission documents as required per protocol, ICH-GCP and local regulations. Ensure amendments to an approved protocol, informed consent form, and other relevant documents are submitted to IRB/IEC for approval as required and assure that changes are not implemented prior to approval. Arrange with monitor the scheduled date, time and location of site initiation visit. Prior to the site initiation visit, review the Investigator's Brochure and any up-to-date information on the investigational product for assessment of risk/benefit ratio of study participation in order to set Site Management Service Plan. Perform study-related tasks delegated by the principal investigator within the contracted scope. Study Nurse is responsible for performing tasks appropriate for its role, unless otherwise noted on a protocol specific delegation of authority log. Support the investigator to identify suitable subjects for screening according to the eligibility criteria. If necessary, assist the principal investigator to use directed and IRB/IEC approved advertising (newspaper, TV, Internet advertisements, posters, etc.) materials. Provide written and verbal site updates on study progress to the line manger according to the study requirements/timelines. Ensure adequacy of information and data contained in site visit reports and other site management documents. Manage the site expenses of clinical trial including but not limited to subject reimbursement, material cost, travelling expense, cost for technical information, utilities and fees.