求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2913-8123
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Clinical Research Associate

  • 全職

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased
o Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and RCPM.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed
- Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities

工作條件

  • 接受身份: 上班族
  • 工作經歷: 二年以上
  • 學歷要求: 大學以上
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: - Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
    - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
    - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
    - Hands on knowledge of Good Documentation Practices
    - Proven Skills in Site Management including management of site performance and patient recruitment
    - Demonstrated high level of monitoring skill with independent professional judgment.
    - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
    - Ability to understand and analyse data/metrics and act appropriately
    - Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO
    - B.A./B.S. with strong emphasis in science and/or biology

福利制度

薪資制度:健全的薪資福利制度、 保障年薪 14 個月、餐費津貼
休假制度:週休二日、特休假12天以上、全年30天給薪病假
保險健康:勞、健保、團體保險 (包含配偶及子女)、員工支持方案(EAP)、健康檢查
訓練發展:完善的教育訓練計劃及員工職涯規劃、教育訓練補助、人才培訓計劃
其他福利:育兒津貼、業務同仁購車貸款利息補助、 員工結婚禮金、生育住院禮品
~以上福利為正職同仁享有~
福 委 會:旅遊津貼、社團活動、年節禮金

更新日期:2019-10-16

應徵方式

  • 職務聯絡人: 美商默沙東藥廠股份有限公司台灣分公司
  • 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: 請至公司官網投遞履歷
    https://msd.wd5.myworkdayjobs.com/SearchJobs/job/TWN---Taipei-City---Taipei-Town/Spclst--Clinical-Research_CLI008836

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年25%
3~5年0%
5~10年50%
10年以上25%
學歷分佈
碩士及以上75%
大學25%
專科0%
高中0%
高中以下0%

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