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.