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Experiences

Current Experience

  • In-house Clinical Research Associate


    Since October 2015

    -performing Investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.

    -utilizing the Clinical Trial Management System (CTMS) to ensure Investigator recruitment activities are accurately tracked.

    -performing essential document collection, review, maintenance and close-out activities, ensuring that sponsor and Investigator obligations are being met and are in Compliance with applicable local regulatory requirements and ich/gcp guidelines.

    -supporting investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and institution review board (irb)/independent Ethics committee (iec) requirements.

    -performing study tracking via CTMS or sponsor designated system to ensure that the study files are current, accurate and complete.

    -documenting site and sponsor contact and study interactions in a timely and professional manner.

    -assisting with resolution of investigational site/data queries.

    -liaising with project team members regarding study site issues.

    -providing quality review of the Informed Consent template.

    -performing study duties in adherence to the science)" rel="nofollow">Protocol, clinical management plan (cmp), study processes, ich-gcp and any other requirements stipulated on the study.

    -following up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator payments.

    -performing other duties as assigned.

    -Performing investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.

    -Utilizing the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.

    -Performing essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.

    -Supporting investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.

    -Performing study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.

    -Documenting site and Sponsor contact and study interactions in a timely and professional manner.

    -Assisting with resolution of investigational site/data queries.

    -Liaising with project team members regarding study site issues.

    -Providing quality review of the informed consent template.

    -Performing study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.

    -Following up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments.

    -Performing other duties as assigned.

Past Experience

  • Graduate Student Researcher

    February 2015 --- June 2015
    exploratory Research into patient participation in Clinical trials.

  • Intern

    September 2014 --- February 2015
    optimizing customer experience.

  • Internal Auditor

    May 2013 --- June 2013
    Internal Audit

  • Assistant pharmaceutical manager

    February 2011 --- January 2013

Knowledge

LinkedIn Assessment :
Project ManagementTeamworkMicrosoft OfficePublic RelationsCoachingHealthcareFlexibilityCommunicationPharmaceuticsdutchTurkishEnglish

Education

  • Bachelor of Health in Pharmaceutical Business Administration, Farmakunde from Hogeschool van Utrecht in 2015
  • HAVO in Natuur & techniek from Pieternieuwlandcollege in 2011

Training and Certification

  • Bachelor of Health in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Turkish
Native
Dutch
Native
English
Professional Proficiency

Area / Region

Amsterdam, Netherlands

Others

Driving License
  • Yes

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