Experience

Research Drive BV

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Trial Assistant/Regulatory Affairs Specialist

  • Oct 2010 - Present

  Responsibilities include: • 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) • EC and Regulatory Submissions responsibilities: • Follow up with EC (central and local) which documents needed • Follow up with Sponsor on documents needed • Follow up with Sponsor on submission dates and make suggestions • Prepare ABR • Prepare ICF/study and site specific • Prepare EudraCT form • Prepare submission letter cEC • Prepare submission letter CA • Prepare submission package local EC(s) including cover letter and local forms (including ABR addendum), if applicable per site • Contact investigator for review of documents • Combine and prepare package for shipment (CA and cEC) • Archiving per submission • Contract negotiation per site Show less



We Support

• Italy
• Renewable Energy Semiconductor Manufacturing

• Office Manager

  • Sep 2012 - Oct 2013

  Responsibilities included: • Correspondence • Maintaining external contacts • Archive • Email handling • Invoicing • Interim support several companies Responsibilities included: • Correspondence • Maintaining external contacts • Archive • Email handling • Invoicing • Interim support several companies



Care and Nursing home Maartenshof Groningen

• Secretary

  • Apr 2006 - Aug 2010

  Responsibilities included: • Correspondence • Diary management • Processing incoming mail • Organize meetings • Taking minutes • Maintaining internal and external contacts • Archive • Email handling Responsibilities included: • Correspondence • Diary management • Processing incoming mail • Organize meetings • Taking minutes • Maintaining internal and external contacts • Archive • Email handling



Shipyard Ferus Smit

• Netherlands
• Shipbuilding
• 1 - 100 Employee

• Receptionist

  • Mar 2005 - Sep 2005

  • Receptionist tasks • Purchase parts • Processing purchase orders • Compiling technical manuals • Email handling • Receptionist tasks • Purchase parts • Processing purchase orders • Compiling technical manuals • Email handling



Armawa Shipping & Trading

• Executive Secretary

  • May 2000 - Dec 2004

  Responsibilities included: • Insurance administration (injury claims, policy administration) • Administration limited partners • Organize annual meetings for limited partners • Correspondence • Taking minutes • Processing incoming mail • Email handling • Management contracts • Purchase printed matters • Directing the receptionist Responsibilities included: • Insurance administration (injury claims, policy administration) • Administration limited partners • Organize annual meetings for limited partners • Correspondence • Taking minutes • Processing incoming mail • Email handling • Management contracts • Purchase printed matters • Directing the receptionist



Rodenstaal BV

• Netherlands
• Mining

• Administrative Assistant Human Resources

  • Jan 1995 - Apr 2000

  • Processing timesheets • Salary administration • Responsible for cash-box • Processing timesheets • Salary administration • Responsible for cash-box



GTG Grootkeukentechniek

• Adminstrative Assistant

  • May 1992 - Dec 1994

  • Typing of tenders • Several administrative tasks • Typing of tenders • Several administrative tasks



Department of Economic Affairs city of Groningen

• Legal Secretary

  • Dec 1991 - Apr 1992

  • Correspondence • Processing incoming mail • Receptionist tasks • Email handling • Correspondence • Processing incoming mail • Receptionist tasks • Email handling



Different agencies

• Several secretary jobs

  • Aug 1990 - Dec 1991

  • Secretary tasks • Secretary tasks