Daniela Alejandra Bernal Vargas

Experience

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  Quintiles

  Jan 2011 - Dec 2011

  Clinical Trial Assistant

  Assist CTLs and CRAs with accurately updating and maintaining clinical systems that track site compliance. Assist the clinical team with the preparation, archiving, handling and distribution of clinical documentation and reports. Assist CTLs with preparation and distribution of clinical trial supplies. Assist with the tracking of CRFs, queries and data flow. Act as a central contact for the clinical team and perform administrative tasks to support team members.

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  Sitel

  Mar 2011 - Sept 2011

  Bilingual Agent

  English and Spanish customer service. Provide with technical support and service to external customers who needs assistance at anytime.

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  SNC-Lavalin

  May 2012 - Dec 2014

  Bilingual Assistant

  External and internal customer service in English and Spanish language. Management of expense reports. Document´s translation and back translation. Files organization.

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  Instituto de Cultura Brasil Colombia

  Jul 2015 - Oct 2015

  Portuguese teacher

  Teach portuguese to people from different ages, based on an interactive and fun teaching system.

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  AuPairWorld

  Oct 2015 - Aug 2017

  Responsible of two kids, help with their homework and their progress in English. It was a good opportunity to practice my French and experience the French culture. Responsible of three children, helping with their homework and with their progress in English. It was an opportunity to improve my French level and to experience the French culture by living with a French family.

  • Au pair

    Sept 2016 - Aug 2017

  • Au pair

    Oct 2015 - Aug 2016
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  High school sainte croix saint euverte

  Sept 2017 - Jun 2018

  Educational assistant

  Responsible for checking the arrival and the departure of the students as well as assisting with their homework. Since it's a boarding school I act as a counselor for the students.

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  Université d'Orléans

  Jul 2018 - Dec 2018

  International Mediator

  Welcome foreign students, check their documents to finish their scholar inscription, give them all the information they need to know the University and to know how to do different process the will need to do in France as foreigns.

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  SODIM Körber Solutions

  Jan 2019 - Oct 2019

  Exports Assistant

  Responsible of all international customer orders from order placement to completion, acting as the liaison with all parties to ensure a smooth and complete transaction.Direct contact with customers in different languages: English, French and Spanish. Process freight claims and customer complaints. Production of accurate export documentation and obtention of export certificates in compliance with each shipment.Timely management of multiple lines of communication between shippers, customers and internal parties, maintaining details and relaying pertinent information to appropriate parties. Initiate timely invoicing and work closely with accounting department to ensure billing accuracy. Show less

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  Freelance, self-employed

  Jan 2020 - Dec 2020

  English and French Teacher

  English and French classes for students of different ages and levels. Classes adapted to the students needs.

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  KieferGarden.com

  Feb 2020 - Mar 2020

  Freelance translator

  Website translation from Spanish to French. Adapting the content to customers in France.

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  Labcorp Drug Development

  Dec 2020 - now

  In House Clinical Research Associate I for studies in the U.S.A.

  · To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites· To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA· To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits)· Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management· To assist with the coordination of study visits and shipment of drug and laboratory samples· To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines· To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment· To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements. As needed regionally· To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings· Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan Show less

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  Fortrea

  May 2023 - now

  House Clinical Research Associate II

  To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session.To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study and discuss potential study risks and opportunities with the Project Manager and CTL.To assist CRAs with preparation for site visits (i.e., running reports, QC of files (checking for missing documents), resolving action items from previous visits)To provide oversight and management of maintenance activities; to ensure compliance with renewals, document, and update according to applicable local regulatory, and IRB/IEC requirements.To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by management.Might be requested to work in a client facing environment as assigned.REMOTE: Perform remote visits (i.e., Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan including remote monitoring that requires SDV/SDR after successful completion of the MEA SDR/SDV training. Show less