北京招聘

Main Accountabilities:

· To ensure all related clinical research operations and procedures are in compliance with protocol, Amador’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

· To be responsible for clinical study sites selection and to ensure these sites can meet the Amador’s requirements and qualified with NMPA.

· To be responsible for clinical trail start-up at sites, include complete GCP submission, obtain the EC approval, and support for the OHGRA application and approval, contract negociation and sign-off.

· To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time.

· To be responsible for submitting documents to site GCP office & EC correctly and on time.

· To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, Amador’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

· To be responsible for using CTMS or required system and trackers in clinical trial and ensure information entered into CTMS or required system and trackers is accurate and updated regularly

· To ensure AEs/SAEs are recorded correctly and reported approprately according to timeline stipulated in clinical study protocols and current regulation.

· To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time.

· To be responsible for transfer Amador study essential documents to TMF on time and consist with ISF.

· To build and keep good working relationship with clinical study sites.

· To be able to complete the above tasks independently with satisfaction.

Role Related Qualifications/ Skills:

· 1-2 years of CRA experience in a CRO or pharmaceutical & medical device company.

· Bachelor’s degree or above in Medical, Pharmacy or related areas.

· Comprehensive knowledge and understanding of ICH-GCP/Chinese GCP and applicable local regulations.

· Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site staffs.

· Fine written, verbal skills, and presentation skills in both Chinese and English

工作地点：北京，天津

Amador Bioscience strives to provide global-standard laboratory, clinical research, strategy consulting and regulatory filing services to biopharmaceutical companies. The laboratory services focus on PK/PD/ADA assay development and sample analysis. Amador clinical research unit specializes in innovative clinical development strategy and protocol design, and initiation and monitoring of clinical studies in China and US. In addition to R&D strategy and regulatory pathway, our consulting services perform global-standard data analysis and generate submission-ready study reports. We have successfully supported CTD filings in China and US.

With profound academic background and rich experience in R&D services in the biopharmaceutical industry, AmadorBio is a global clinical research team of pharmacologists, statisticians, bioanalytical scientists, translational & clinical scientists, medical scientists, clinical trial management experts, data management experts, quality assurance auditors, clinical trial managers and regulatory specialists. (40% of PhD, MD and PharmD, 35% of MS). AmadorBio provides professional services for more than 20 leading biopharmaceutical companies from early research and development, clinical development to regulatory submission in China and US.

AmadorBio operates in biotech hubs: San Francisco Bay Area, USA and Shanghai-Hangzhou-Suzhou region, China, providing comprehensive solutions complied with global standards and government drug inspection regulations in China and US.

The mission of Amador is to provide global-standard services facilitating the development of novel biotherapeutics.

    安渡生物致力于为生物医药公司提供全球标准的实验室、临床研究、策略咨询和监管申报服务。实验室服务专注于PK/PD/ADA方法学开发验证和样本分析。安渡生物的临床研究中心专注于为美国和中国的生物医药公司提供创新的临床研究开发策略、方案设计、启动和监查的专业服务。我们的咨询服务除研发策略和监管服务外，还可提供全球标准的数据分析并生成完备的申请报告。我们在中国和美国成功地支持了多家医药公司的CTD申请。

    安渡生物是一支具有资深学术背景、行业研发服务经验丰富的临床研究团队，拥有临床药理、数理统计、生物分析、转化科学、医学、临床运营、数据管理、质量保证审核、项目管理以及监管申报各方面专家，其中博士(PhD, MD, PharmD)占40%，硕士占35%。安渡团队致力于支持从临床前到临床各个阶段的药物开发计划。目前我们为20余家中美生物制药公司提供从早期研发，临床开发到监管申报等多个项目的专业服务。

    安渡生物在美国旧金山湾区和中国长三角地区设有办公室和实验室，提供涵盖中美及符合国际标准和政府药检规范的全方位解决方案。

    安渡生物的使命：提供全球标准的服务，促进新型生物药物开发。