Andrea Mecklenburg
Munich, Germany
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
- SPECIAL EXPERIENCE as unblinded CRA
- 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…)
Employments
- Since 12/2003 freelance Clinical Research Associate
- 2000 – 2003 Clinical Research Associate (employed, two CROs)
Training/Qualification
- 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.
