南京招聘

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）是一家成立于1997年的临床CRO公司。总部设立于上海，并分别在台北，徐州，北京，南京，首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今，PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目，其中涉及24个主要研究领域。
     另外，PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年，PPC佳生在台北（MacKay Memorial Hospital）建立了***家专属I期临床研究中心；2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前，PPC佳生已有5家自主运营的I期临床中心。