CTA 临床助理

该职位来源于猎聘 Description: •* Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements. •* Supports the local study team in performing site feasibility and/or country feasibility.

•* Maintains site level protocol information in Trial Management Systems (e.g. CTMS). •* In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes. •* Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval

• Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
• Supports the SM/LTM in collecting and maintaining all documents throughout the trial and posttrial in both eTMF(i.e., IF/LAF sections) and paper files. •* Distributes, collect, review, and track regulatory documents, agreements and training documentation. •* Collects and tracks Financial Disclosure information at appropriate time points. Profile:
• Skills set corresponding with preferentially 0-2 years relevant clinical trial experience or equivalent.
• Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.