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 Site Monitor

  • 全職

Responsibilities:
· Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other
medical contacts. Assess potential Investigators and their sites. Documents the
visit
and communicate findings. Provides feedback on Potential Site Assessment
findings to collaborators.
· Recommends sites for consideration in future studies, as needed.
Expedites the pre-study and study initiation processes including the conduct of
pre-study evaluation and site initiation visits. Conducts initiation visits in
collaboration with clinical site managers, field medical and/or protocol
managers. Orients and trains site personnel regarding the protocol, study
related processes and procedures and applicable regulatory requirements.
· Ensure study milesones and recruitment target achieved. Reviews site
activities and quality through on-site visits in addition to remote management
capabilities. Monitors study sites following the monitoring plan, BMS SOPs,
protocol, ICH/GCP Guidelines and other local regulations as applicable. This
includes, but is not limited to: Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location
and/or geographic territory.
· Ensures safety and protection of study subjects according to the
monitoring plan, SOPs, and ICH/GCP Guidelines and local regulations. Ensures
quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities.
· Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrollment and retention goals. Resolves study site problems/issues as they occur.
More complex issues may be resolved jointly with management. Initiates,
recommends, documents and communicates corrective actions as needed and
follows up to ensure corrective actions are implemented.
· Ensures documented follow-up to all outstanding issues/corrective
actions, within the scope of this position profile, in the available systems.
Appropriately documents and promptly escalates serious or persistent
outstanding issues to management and project team.
· Facilitates the Regulatory Compliance audit process, as needed.
· Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
· Identifies opportunities to interact, builds and strengthens professional
and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues, etc.).

Requirements:
· Bachelor’s degree in Pharmacy or relevant, at least 1-2 years of site
monitoring experience .
· Ability to manage multiple protocols across multiple therapeutic area,
Knowledge of clinical trial conduct including HA requirements and ICH GCP.
· Good command of English communication, Excellent communication
skills (written and verbal) & Excellent organization skills.
· Reviews site activities through on site/ off site monitoring and contact to monitor study sites as per monitoring plan and the applicable BMS SOPs, to
ensure data integrity /patient safety, study milestones/recruitment achieved and maintain strong site relationship.

工作條件

  • 接受身份: 上班族
  • 工作經歷: 一年以上
  • 學歷要求: 大學
  • 語文條件: 不拘
  • 其它條件: 未填寫

福利制度

◆ 獎金 / 禮品類
 1.年終獎金
 2.三節獎金/禮品
◆ 保險類
 1.勞保
 2.健保
 3.員工團保
 4.眷屬團保
◆ 制度類
 1.伙食津貼
 2.介紹獎金
 3.順暢的升遷管道及短、長期國外外派機會
◆ 請 / 休假制度
 1.週休二日
 2.特休/年假
 3.陪產假
 4.不扣薪病假
 5.家庭照顧假
 6.女性同仁生理假
◆ 其他
 1.員工健康檢查
◆ 補助類
 1.結婚禮金
 2.社團補助
 3.旅遊補助

更新日期:2019-05-22

應徵方式

  • 職務聯絡人: 周思敏
  • 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

應徵分析

兩週內11-30人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年46%
5~10年0%
10年以上54%
學歷分佈
碩士及以上62%
大學31%
專科0%
高中0%
高中以下0%
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