Ref #: 29926
Employment type: Permanent – Full-Time
Location: Turkey
Posted: 11-Jun-2021
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.
* 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.
Apply now
Apply now
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