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InVentiv Health Clinical France
- Clinical Document Associate
2012 - maintenant
* Create and maintain the Trial Master File (TMF) document repository for multiple protocols
* Inventory and archive clinical documents and project related materials, including scanning and indexing documents for electronic (eTMF) studies
* Perform quality –control (QC); interactions with the clinical project team
* Perform proactive document collection activities to achieve audit-readiness
* Attend and support file audits and liaise with Quality Assurance department to resolve audit findings as appropriate
* Maintain compliance with company requirements
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I3 Research / PharmaNet/i3
- Project Research Assistant
2007 - 2012
* Attend project meetings, take notes, and issue minutes as needed.
* Track enrollment data from sites and compile reports for the Clinical Project Manager.
* Communicate with sites to ensure enrollment data are collected in a timely manner.
* Request and track documents, and prepare correspondence to ensure that required forms
are completed at the site and provided for review.
* Track monitoring reports and follow up correspondence to the study sites to assist the Clinical Project Manager in ensuring reports are provided to sponsor in a timely manner.
* Schedule teleconferences.
* Prepare study related reports.
* Maintain project clinical trial management system.
* Generate correspondence as directed.
* Screen and prioritize phone calls.
* Prepare and ship investigator notebooks.
* Assist in compiling Clinical Operations Manual for assigned projects.
* Provide study-related forms and supplies to sites and monitors.
* Code project documents for central filing (including Regulatory documents).
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I3 Research
- CRA trainee (training course)
2007 - 2007
* Performed feasibility studies (exocrine pancreatic insufficiency, deep venous thrombosis)
* Performed 2 pre-study visits (cancerology and psychiatry)
* Performed 1 monitoring visit in cancerology (preparation, cross-checking CRF against source documents, investigator site file’s check and update, ESR reconciliation, shipment of CRF pages)
* Written visit reports (PSSV)
* Participated in filing
* Created study documents
