Clinical Research Associate
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-08-12
- 工作地点:广州-越秀区
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:本科
- 职位月薪:1-2万/月
- 职位类别:生物工程/生物制药
职位描述
Major Responsibilities
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
- Conducts co-monitoring visits, if required
- Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends onboarding-, disease indication and project specific training and general CRA training as required
- Documents monitoring activities appropriately following ICH-GCP and BeiGene standards
- Conducts Quality Oversight Visits (QOV), as requested
- Completes monitoring visit/ QOV reports timely
- Assists with investigator/site identification
- Assists site to prepare Ethics Committee submissions
- Facilitates clinical trial site contract and budget negotiation
- Manages site queries and communications
- Assists in managing clinical trials, if required
- Establishes regular lines of communication with sites and COMs
- Provides protocol and related study training to assigned sites
- Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
- Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
- Performs additional task as assigned
Qualification
- Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical ? Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English (writing and speaking)
职能类别: 生物工程/生物制药
公司介绍
百济神州是一家立足于科学的全球性生物科技公司,专注于开发创新、可负担的药物,旨在为全球患者改善治疗效果,提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作,加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)