北京招聘

The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the country.
The CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
?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
职位要求：
?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 2 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry
?ExcellentGood communication and interpersonal skills
?ExcellentGood organizational skills and ability to prioritize and multi-task
?Good problem-solving skills
Good command in verbal and written EnglishFluent in English (writing and speaking)

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。