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更新于 4月30日

FSP 臨床試驗(yàn)協(xié)調(diào)員CTC (物質(zhì)管理方向)

1-1.2萬·13薪
  • 北京
  • 經(jīng)驗(yàn)不限
  • 本科
  • 全職
  • 招1人

職位描述

藥品臨床研究CTA臨床試驗(yàn)助理
*可接受醫(yī)藥相關(guān)專業(yè)優(yōu)秀學(xué)歷背景的應(yīng)屆畢業(yè)生-2024/2025屆
*臨床物資發(fā)放,輔材設(shè)備進(jìn)出口管理,庫存管理,供應(yīng)商管理等 This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs, the person prepares, collates, distributes and archives clinical documents.
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role will collaborate at local level closely with COM, CRM and CRA.
Responsibilities include, but are not limited to: - Trial and site administration: o Clinical supply & non-clinical supply management, in collaboration with other country roles o Manage Labeling requirements and coordinate/sign translation change request - Clinical supply and ancillary supply management: o Conduct clinical supply local purchase when global central sourcing is not available o Conduct ancillary supply local purchase - Document management: o Prepare documents and correspondence o Collate, distribute/ship, and archive clinical documents, e.g. eTMF o Assist with eTMF reconciliation o Execute eTMF Quality Control Plan o Document proper destruction of clinical supplies. o Prepare Investigator trial file binders o Obtain translations of documents CORE Competency Expectations: - Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands on knowledge of Good Documentation Practices - Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required. - ICH-GCP Knowledge appropriate to role - Excellent negotiation skills for CTCs in finance area Behavioral Competency Expectations: - Effective time management, organizational and interpersonal skills, conflict management - Effective communication with external customers (e.g. sites and investigators) - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus, both internally and externally. - Able to work independently - Proactive attitude to solving problems / proposing solutions
Experience Requirements: - Minimum 1 - 2 years in Clinical Research or relevant healthcare experience Educational Requirements: - Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.

工作地點(diǎn)

北京朝陽區(qū)酒仙橋路10號(hào)恒通商務(wù)園B20座1層102室

職位發(fā)布者

劉女士/HR

三日內(nèi)活躍
立即溝通
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