台灣立力科股份有限公司

Communicate with the trial team, trial sites and suppliers to ensure timely initiation and high-quality completion of clinical trials. Prepare clinical trial site qualification documents. Assist in reviewing the documents to ensure that the clinical trial sites comply with ICH-GCP and relevant local regulations. Key Responsibilities Include: • Assist clinical study team members in preparing, supervising and reporting of clinical trials in accordance with regulatory requirements and relevant standard opening procedures (SOPs) • Set-up maintain project filing for designated studies (paper and electronic filing systems for records) • Assist in preparation, correction, formatting of study-related documents (e.g. Protocol, Patient Information and Informed Consent Form etc.) • Assist in preparation of presentations for study teams members • Collect, file and distribute study-related documents (e.g. preparation and maintenance of Trial Master File (TMF)) • Assist the study team members in implementation activities where required. Preparation, collection of Regulatory and Essential Documents, facilitation of IRB/IEC submission and approval process • Preparation of Investigator Site File (ISF) e.g. for site initiation • Set-up and maintenance of tracking systems, reliably and efficiently input data into tracking systems to facilitate timely access by the study team members e.g. patients, sites, essential documents. Serious Adverse Events, CRFs and data queries as required for assigned projects • Take on any other task as assigned by manager or project team • Participate in relevant study/job related trainings • Assist in the planning and preparation of meetings, conferences and conference telephone calls • Provide general administrative support for personnel and liaise with HQ and subsidiary personnel as needed • Support site budget negotiation and site payment per site contract as needed • Support or directly perform IRB/EC and regulatory submission • Support or directly perform regulatory submission as needed • Provide support for audits/ inspections as needed • Support project team for import/export activities related to IP/non-IP supplies • Coordinate shipmen/ return/ destruction • Manage inventory and re-supply, as applicable • Support re-labelling in compliance with internal/external regulations • Act as primary administrator for customs clearance • Filing/ Copies/ Archiving Personal Skills: • Ability to work in a team and independently • Effective time management and organizational skills • Sense of responsibility

1. 人事招募:提升公司人事管理規章與召募任用制度，人事檔案建置與管理。 2. 薪酬處理: 管理人事系統與工作規則。 3. 勞資關係:建置維持良好員工關係及關懷制度，勞資關係協調與諮詢 。 4. 負責行政事務流程之溝通、整合及規劃。 5. 總務行政事項（如：行政相關單據報銷）。 6. 每月提供各項管理報表。 7. 委外簿記公司聯絡窗口 8. 處理軟硬體相關業務(與委外IT聯繫、廠商報修等)。 9. 需與日本總公司聯繫，配合交辦事項。 ※需具備商業溝通英文能力或日語能力