Andrea Mecklenburg

Professional experience

03/2003 – present: Freelance CRA

  • EXPERIENCE in performing the clinical monitoring aspect of international clinical trials phase I-IV in accordance with the ICH GCP Guidelines, EMEA Guidelines, legal regulations and appropriate SOPs, including identifying, qualifying and initiating sites, performing interim, close-out and co-monitoring visits, site audits/inspection preparation and participation, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, training/coaching junior staff
  • EXPERIENCE in Risked Based Monitoring
  • EXPERIENCE as Data Monitor
  • EXPERIENCE as Safety Manager (IIT)
  • SPECIAL EXPERIENCE in the conduct of paediatric studies (hypertension, bronchial asthma, McCune-Albright-Syndrome) and experienced paediatric nurse in different fields (e.g. intensive care, oncology/BMT)
  • SPECIAL EXPERIENCE in the conduct of oncological studies (colorectal cancer, Non-Hodgkin’s lymphoma, glioblastoma, ovarian cancer, bladder cancer)
  • SPECIAL EXPERIENCE in studies with controlled substances
  • SPECIAL EXPERIENCE in studies with orphan diseases
  • SPECIAL EXPERIENCE in studies in ICU
  • OTHER THERAPEUTIC AREAS OF EXPERIENCE: allergology, cardiovascular diseases, endocrinology, ENT, geriatrics, immunology, infectiology, neurology, nephrology, rheumatology, psychiatry, transplantation
  • EXPERIENCE in various Clinical Trial Systems (EDC, IVRS/IWRS, electronic monitoring systems…)


  • Since 12/2003 freelance Clinical Research Associate
  • 2000 – 2003 Clinical Research Associate (employed, two CROs)


  • Since 2000 continuous qualifications in processes of clinical research

Detailed CV incl. record of monitored clinical studies and performed training will be provided upon request.

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