Ref #: 27063

Employment type: Permanent - Full-Time

Location: Mexico

Posted: 22-Feb-2021

Description

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 process.
•* 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.
•* May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
•* May be assigned as a coach and mentor to a less experienced CTA.

Profile:
* Skills set corresponding with preferentially 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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