Clinical Trial Assistant (CTA) *** Spain *** Office based - M-680

Clinical Trial Assistant (CTA) *** Spain *** Office based - M-680

03 nov
|
DOCS
|
Madrid

03 nov

DOCS

Madrid

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.



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