北京招聘

职位描述：
*Responsibilities/Duties
? Develop project specific plans for the GSS component of assigned studies, liaise with operational project team regarding project issues (i.e., participate in team meetings)
? Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
? Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
? Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
? Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility, and obtain further detailed information regarding potential proposals
? Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report
*Education/Qualifications
? University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
*Experience
? 3 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
? Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
? Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
? Good organizational and time management skills, excellent communication / writing skills
? Self-motivation with the ability to work under pressure to meet deadlines, works well independently as well as in a team environment 举报 分享

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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