上海招聘

Responsibilities:

Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.

• Evaluation potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites.

• Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.

• Assist PM in start-up meeting.

• Prepare and manage the clinical trial agreements with investigators/sites.

• Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.

• Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.

• Monitor and report the project status at the sites in a timely manner.

• Key contact person for the communication between the sites and study team.

• Prepare, arrange and conduct the training of site personnel.

• Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.

• Prepare monitoring report according to the SOP.

• Assist the investigator for auditing/inspection of project.

• Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.

• Identify, analyze and resolve the issues at the investigator sites.

  Qualifications:

  A 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.

  At least 1 year experience in clinical research environment.

  Good command of written and spoken in English or other second language.

  Good organization and communication skills.

  High attention to detail and accuracy.

PPC佳生集团（PPC Group）成立于1997年，是一家专注于提供药物临床研究一站式专业服务的合同研究组织（CRO），服务范围包括注册咨询、医学事务、临床监查、项目管理、数据管理、统计分析及药物安全警戒。PPC佳生集团总部位于中国上海，在中国大陆、中国台湾地区、韩国和日本提供全面的临床研究和实验室服务。PPC佳生集团旗下拥有1个Ⅰ期临床研究中心，4个生物分析实验室和1个中心实验室。

Novotech成立于1996年，是亚太地区***的合同研究组织（CRO）。Novotech的服务范围覆盖澳大利亚、新西兰和亚洲各地，其服务质量得到了客户和业内的认可。

2020年10月，两家亚洲领先的合同研究组织（CRO）—— Novotech与PPC佳生集团(以下简称"PPC佳生")合并成立了Novotech Health Holdings，旨在打造一个充分契合并具有多地域覆盖规模性的合同研究组织（CRO）平台，以满足亚洲地区快速增长的优质临床试验服务的需求。合并后的新公司将成为亚洲***的生物技术专业CRO平台，可提供从首次人体到IV期临床研究的全面临床服务。Novotech Health Holdings目前拥有超过2075人的国际化专业团队，在14个国家和地区拥有21个办公地点。