Experience

Research Drive BV

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Trial Assistant / Regulatory Affairs

  • Dec 2005 - Present

  Responsibilities include: • Support to General Manager • Invoicing • Human Resources • CTA activities • Provide clerical and administrative support to project teams • Set-up and maintain project files (Trial Master Files, General Master Files, Site specific files) • Set-up investigator files • Fax, photocopy, and distribute study-related documents • Contact study personnel at sites regarding administrative issues • Order office supplies as needed by project team • Generate and maintain study-specific tracking spreadsheets (e.g., patient enrolment, regulatory documents, site visits, investigator payments) • Ship/mail supplies and documents to clients, investigator sites, and IRBs • Assist in assembling materials and binders for Investigators‘ Meetings • Prepare regulatory binders (Study File Notebooks) for study sites • Maintain Research Drive Investigator Databank (i.e., update database with new entries, provide reports to Project Managers and/or Business Development personnel, as needed) • Attend client meeting and teleconference and assist in writing of meeting minutes • All other administrative tasks (archiving etc) • Assisting CRA’s with accountability and TMF • EC and Regulatory Submissions responsibilities: o Follow up with EC (central and local) which documents needed o Follow up with Sponsor on documents needed o Follow up with Sponsor on submission dates and make suggestions o Prepare ABR o Prepare ICF/study and site specific o Prepare EudraCT form o Prepare submission letter cEC o Prepare submission letter CA o Prepare submission package local EC(s) including cover letter and local forms (including ABR addendum), if applicable per site o Contact investigator for review of documents o Combine and prepare package for shipment (CA and cEC) o Archiving per submission o Contract negotiation per site Show less



VCD IT Groep

• Groningen, Netherlands

• Secretary

  • Apr 2000 - Aug 2005

  Responsibilities included: • Support to Director • Responsible for incoming and outgoing correspondence • Hour registration of the department • Prepare and manage correspondence, reports and documents • Maintain the general filing system and file all correspondence • Assist in the planning and preparation of meetings and conferences • Providing office and clerical services to the department Systems & Integration Responsibilities included: • Support to Director • Responsible for incoming and outgoing correspondence • Hour registration of the department • Prepare and manage correspondence, reports and documents • Maintain the general filing system and file all correspondence • Assist in the planning and preparation of meetings and conferences • Providing office and clerical services to the department Systems & Integration



Tebodin, Consultants & Engineers

• Department secretary

  • Aug 1992 - Apr 2000

  Responsibilities included: • Support to Director • Responsible for the secretary department • Responsible for incoming and outgoing correspondence • Responsible for office supplies • Hour registration of the complete company • Prepare and manage correspondence, reports and documents • Maintain schedules and calendars • Maintain the general filing system and file all correspondence • Assist in the planning and preparation of meetings, conferences and conference telephone calls • Providing office and clerical services to all departments Show less