(臨床試驗部)臨床試驗專員 (Clinical Research Associate, CRA)

✤Provide general administrative support to the Clinical Trial Department. ✤Communicate with investigational sites to collect all essential documents before the study start-up. ✤Preform TFDA submission such as initial, ongoing, amendment, safety reporting, and study notification per regulatory requirements and obtain the approval within the forecasted project timeline. Support IRB submission as needed. ✤Assist the Clinical operations teams with ongoing conduct of studies, including but not limited to the internal payment application process, study tracking update, document filing, document translation, audit preparation, and final reconciliation and archival. ✤Set up, prepare, distribute and maintain the study documentation and reports (e.g. Trial Master File (TMF), Case Report Form (CRF), etc.) according to the scope of work and Standard Operation Procedures (SOPs). ✤Order, dispatch and track the study materials (e.g. CRFs, diary cards, lab supplies, etc.) as appropriate. ✤Maintain the completeness of TMF at site and/or country level. ✤Organize and coordinate the team meetings and take meeting minutes. ✤Participate in the internal and external meetings, take meeting minutes and provide status updates as required. ✤Maintains a positive collaborative relationship internally and externally. ✤Participate in the development of protocols, informed consent form (ICF) and CRF as assigned. ✤Perform other duties as assigned by management team. ✤May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. 1. Conduct site initiation, monitoring and close-out visits for assigned studies (includes project of Regulations of Special Medical Techniques (Specific)) in accordance with regulations, Standard Operation Procedures (SOPs), Good Clinical Practice (GCP), and Monitoring Plan (MP). 2. Deliver site training on the protocol and applicable regulatory requirements and perform site monitoring and management to ensure successful execution of the protocol. 3. Perform the study start-up activities, prepare the regulation submission and negotiate the site budgets. 4. Maintain the completeness of Trial Master File (TMF). Review the status and contents of essential documents and reconcile with TMF at site and/or country level. 5. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Forms (CRF) completion, and data query generation and resolution. Initiate appropriate actions to achieve study milestones. 6. Create and maintain appropriate documentation regarding site management, monitoring visit findings, correction plans, and action plans by submitting the visit reports, generating follow-up letters and other required study documentation. 7. Evaluate the quality and integrity of study site practices related to the protocol and escalate quality issues as appropriate. 8. Ensures safety and protection of study subjects through compliance with the MP, SOPs, and applicable regulations. Track and follow-up on Serious Adverse Event (SAE) reporting to ensure the reporting timeline meet regulatory requirements. 9. Collaborate with study team members for project execution support as appropriate. 10. Participate in the development of protocols and CRF as assigned. 11. Assist with training and mentoring of new employees as assigned. e.g. co-monitoring. 12. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned. 13. Perform other duties as assigned by management team.