1. Design CRF based on study protocol and prepare the CRF completion guideline.
2. Generate data management plan and data validation plan.
3. Clinical Data Management / Clinical data management status report.
4. Provide training to the site personnel and reporting agencies on proper data collection processes.
5. Coordinate with clinical monitoring activities to help provide prompt feedback to sites on data quality.
6. Establish data quality standards and works with reporting agencies to ensure standards are met.
7. Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.
CRA for BE study/New drugs/Medical devices
1.Clinical research study setup/study procedure setup/site staff training
2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP
3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports
4.regular report to sponsor/communication between sponsor and site.
5.site close-out/trial materials retrieval
6.audits/regulatory inspection participation upon request
1. Draft, review, and finalize clinical study documents in compliance with ICHGCP,
applicable regulatory guidelines, and sponsor specifications, including
but not limited to:
▪️Clinical study protocols and protocol amendments
▪️Investigator’s brochures (IB) and IB updates
▪️Clinical study reports
▪️Informed consent forms
▪️Briefing documents for regulatory meetings
▪️Patient narratives and safety summaries
▪️Clinical sections of regulatory submissions (e.g., CTD Module 2.5, 2.7)
2.Ensure scientific accuracy, clarity, and consistency of content across all
documents
3.Collaborate cross-functionally with biostatistics, data management, clinical
operations, medical affairs, pharmacovigilance, and regulatory affairs teams
Interpret statistical and clinical data for integration into reports and summaries
4.Follow internal SOPs, writing style guides, and client-specific templates or
standards
5.Maintain awareness of current regulatory requirements and industry best
practices in clinical documentation
6.Assist in developing and maintaining document timelines, ensuring timely
delivery
7.Respond to quality control or medical/scientific review comments and
incorporate revisions accordingly
8.Hold PI meetings, and present protocols and clinical trial results to PIs and
relevant personnel
9.Undertake other MA-related tasks as assigned by the line manager
負責臨床試驗中心啟動、文件收集與送審、合約及預算談判。
Responsible for site initiation, regulatory document submission, and contract/budget negotiation.
維護研究中心合作關係,確保試驗順利進行至結案。
Maintain active collaboration with investigator sites to ensure smooth trial conduct and closure.
確保所有流程遵循 GCP、當地法規及公司政策,並維護試驗文件。
Ensure compliance with GCP, local regulations, and company policies, while maintaining accurate trial documentation.
管理臨床試驗物資、付款流程及相關財務事務。
Manage clinical trial materials, payment processes, and related financial activities.
協助流程優化,並在高階職級中領導跨部門協調與團隊指導。
Support process improvement, and in senior roles, lead cross-functional coordination and provide team guidance.
**
具臨床試驗或相關經驗:
有1-3年工作經驗,具備熟稔送審(含IRB、TFDA等)相關事宜,如有談預算/或合約經驗者更佳
**
特休: 入職即可享用8天 第二年13天
病假:10天
旅遊補助:每年皆有1-3萬的補助可使用
ICON公司為全球前五大CRO 臨床試驗機構,全球第一大FSP公司,與全球頂尖的藥廠合作,提供專業的臨床研究服務。
提供員工良好且完整的教育訓練,透明的升遷制度,完善的休假制度,周休二日,讓員工能在良好的支援下為世界提供更新、更好的新藥品。
臨床試驗專員
1.藥品臨床試驗計畫啟動至結案過程的觀測及監督。 須具備良好的溝通能力以及敏捷的緊急應變能力,能跟試驗單位進行良好的溝通,並協助案件進行。
2.臨床試驗相關個案報告整理。須具備良好的檔案管理能力。
3.工作型態:需要出差到試驗單位(醫院),查看臨床試驗的進度,並定期回報給專案經理,確認試驗持續符合計畫案的里程碑。出差天數依據試驗案的進程而定。
4.具備良好的英文讀寫能力,所有公司文件皆以英文撰寫。
5.目前需要具備一年以上的臨床試驗案進行經驗的人才。職級及薪水的核定將以面試來決定。面試有兩關,約在兩周內就會完成。
6. 歡迎持有身心障礙證件者投遞
Responsibilities
The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include:
1. Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out.
2. Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.
3. Develop effective relationships with investigator site staff to ensure that key clinical metrics are met.
4. Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies, and following up on drug safety issues.
5. Ensuring the integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines
6. Negotiation and ongoing management of clinical trial agreements with investigative sites.