上海招聘

1. Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements as lead CRA. 

2. Oversees site feasibility, qualification and selection process; establish monitoring plans, conducts site monitoring visits, manages study monitoring schedule to ensure adherence to timelines; ensures team members compete action items in a timely manner. 

3. Maintains audit-/inspection-ready clinical study status with supervisors.

4. Ensures that necessary study supplies (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.) are available at sites as necessary, by working with clinical supply team. 

5. Coordinates specified periodic clinical trial meetings (e.g., investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, managing preparation of necessary materials, training clinical site personnel on study procedures, and being responsible for recording and distributing minutes. 

6. Manages payment procedures for clinical studies, prepares site invoices, supporting documentation and application forms, initiates/creates Purchase Orders as necessary. 

7. Manages and helps create clinical trial tracking metrics and reporting for internal and external collaborators. 

8. Other assigned tasks.

任职要求：

1. At least 3.5 years of clinical monitoring experience；

 2. Clinical Research Associate certification and/or Good Clinical Practice training certification desirable. 

3. Extensive experience as a Sr.CRA including the ability to interact effectively with investigators and cross-functional teams. 

4. Professional use of the English language, both written and oral, is required. 

5. Excellent verbal and written communication skills. 

6. Active aptitude and demonstration on comprehensive and current knowledge in relevant therapeutic or product areas assigned. 

7. Strong computer skills including knowledge of MS-Office products. 

8. Able to take initiative and work independently.

    爱科百发生物医药是一家专注于抗病毒创新药研究及开发的生物技术公司，致力于成为全球性的抗病毒创新药及儿科药研发生物技术公司，成立6年多以来已成立核心研发和管理团队，运营良好。公司总部坐落于中国药谷上海张江高科技园区，此外还在中国苏州、澳大利亚设立分公司。公司目前主要研发产品抗呼吸道合胞病毒（RSV）的新型药物已经完成临床II期试验阶段，并有望成为全球***个专门用于抗RSV病毒感染的临床药品，另有3个应用于流感病毒和乙肝治疗的产品处于研发阶段。