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Опубликовано 1 день назад

Clinical Research Associate

ManpowerGroup Ukraine

verifiedпроверено

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branchФармацевтика

cityКиев

contactАлена

sitehttp://www.manpowergroup.com

  • полная занятость
  • английский

Responsibilities:

  • Perform feasibility studies/site identification activities for potential sites, as requested
  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification etc.)
  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
  • Assure maintenance of the Investigator Site File in the TMF
  • Conduct pre-study, study initiation and interim monitoring visits under the guidance of the local CRA or LCRA/PM, as applicable and appropriate
  • Document site visit findings at site visits via written reports, under the guidance of the local CRA or LCRA/PM, as applicable and appropriate
  • Maintain regular communication with sites
  • Complete remote CRF review, using electronic data capture systems
  • Assist sites in query resolution
  • Assist with ensuring site compliance with IP receipt, accountability and return or destruction, as applicable and appropriate

Requirements:

  • Basic understanding of clinical research principles and process
  • Basic understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements, training provided by WCT
  • Good understanding of FDA and / or EU Directive regulations, ICH Guidelines and local regulatory requirements as required, training provided by WCT
  • Good understanding of standard operating procedures, training provided by WCT
  • High level of proficiency in both spoken and written English.

 

 

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