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臨床監(jiān)查員CRA

1-1.5萬·13薪
  • 成都錦江區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

ICHGCP
崗位職責:
1. The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and
reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable, Regulatory requirements.
2. Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines
3. Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
4. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
5. Provides regular site status information to team members, trial management, and updates trial management tools
6. Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
7. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
8. Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
9. Performs essential document site file reconciliation
10. Performs source document verification and query resolution
11. Assesses IP accountability, dispensation, and compliance at the investigative sites
12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
13. Communicates with investigative sites
14. Updates applicable tracking systems
15. Ensures all required training is completed and documented
16. Be assigned logistical support tasks by CTM for Investigator Meetings
任職要求:
1. 2 to 4 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical research experience
2. Knowledge of ICH and local regulatory authority regulations regarding drug
3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)
職位福利：五險一金、通訊補助、帶薪年假、彈性工作、餐補、試用期全額、績效獎金、定期體檢

工作地點

成都錦江區(qū)東御街18號百揚大廈1棟2803-2804室

職位發(fā)布者

陸曉玲/SrHR

立即溝通
公司Logo上?？档潞胍磲t(yī)學臨床研究有限公司
康德弘翼（WuXi Clinical），是藥明康德（WuXi AppTec）的一家全資子公司。始終致力為全球客戶提供全方位的臨床研究服務(wù)，包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產(chǎn)品，涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗。通過嚴格的質(zhì)量控制體系和專業(yè)團隊的豐富經(jīng)驗，幫助創(chuàng)新性，突破性醫(yī)藥產(chǎn)品盡快上市和造福患者?？档潞胍砹⒆阒袊?，面向世界，以上海總部為中心，輻射全球制藥公司、生物技術(shù)公司以及醫(yī)療器械公司。目前，公司實行全球聯(lián)合運營，人員規(guī)模達850+人，運營能力覆蓋中國、美國及澳大利亞等，并在上海、北京、廣州、武漢、成都、長沙、西安、沈陽、中國臺北、美國奧斯汀、美國圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團隊與各研究中心建立了良好的合作關(guān)系，始終保持著緊密的業(yè)務(wù)交流，保證了項目能高效、高質(zhì)地完成。隨著業(yè)務(wù)能力和業(yè)務(wù)范圍的不斷拓展，康德弘翼進一步完善和增強了全球一體化研發(fā)服務(wù)平臺的綜合實力，助力全球創(chuàng)新合作伙伴更好、更快地開發(fā)醫(yī)藥產(chǎn)品。
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