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台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
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廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Study Start-Up Specialist 臨床試驗開創專員

  • 全職

* Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
* Executes all start-up activities prior to site activation on assigned studies, according to Roche standards and aligned with study/project requirements and timelines.
* Prepares country level Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
* Maintains and analyses study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
* Partners with Clinical Study Managers (CSMs) and Clinical Study Specialists (CSSs) to provide guidance on regulatory / ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions /activations.
* Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/laws, via innovative approaches.
* Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SSUARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).
In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
* Responsible for study budget and contracts negotiation in collaboration with Contracts Manager / Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.

工作條件

  • 工作經歷: 不拘
  • 學歷要求: 大學 碩士
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: 1. University degree or equivalent in a medical/science-related filed
    2. Prior work experience demonstrating knowledge and understanding of clinical trials
    3. Demonstrated knowledge an understanding of ICH-GCP/GPP, the regulatory, ethics an contractual requirements for starting clinical trials
    4. Able to prioritize and manage multiple tasks with high flexibility.

福利制度

1) 勞健保外,另提供完善團保制度
2) 定期健康檢查
3) 彈性福利計畫
4) 年度旅遊補助
5) 員工在職訓練
6) 汽車貸款
7) 股票優惠認購

更新日期:2022-01-04

應徵方式

  • 職務聯絡人: 人力資源處
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽
  • 它: 請郵寄履歷表,合者約談,請勿來電。

應徵分析

兩週內11-30人應徵
經歷分佈
新鮮人9%
1~3年9%
3~5年55%
5~10年9%
10年以上18%
學歷分佈
碩士及以上64%
大學36%
專科0%
高中0%
高中以下0%
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