Lead CRA, Projektmanager, Auditor, Trainer

12/1994 – offen

Free lance work - mainly for different CROs or direct cooperation with pharmaceutical companies: Project Management and Monitoring (mainly lead CRA) of clinical trials for drugs and medical devices; Quality Assurance (auditing, SOP writing), medical writing, training of monitors and study sites

Clinical research:
Project management, investigator recruitment of and monitoring and/or co-monitoring for numerous international phase I - III studies, including various FDA and biogenetic studies in Germany, Austria, Switzerland, Lithuania, Bulgaria, Croatia, Poland, Russia:
Medicinal products: Rheumatoid arthritis, osteoarthritis (several studies), various pain model studies [low back pain, hip replace¬ment, hernia repair, knee replacement; pain in diabetic polyneuropathy; transdermal Patient Controlled Analgesia (PCA), heart deficiency, coronary heart disease, hypertension, atrial fibrillation, circulatory disorders (thrombocyte aggre¬gation), diabetes mellitus type IIb, multiple sclerosis, psoriasis, diagnosis of oral cancer (SCC), colorectal cancer, renal cell cancer, lung cancer (mesothelioma), depression, immunosuppression after heart transplantation, pharmacokinetic and pharmaco¬dynamic of a human granulocyte colony-stimulating factor (G-CSF), antibiotic therapy of community-acquired pneumonia (CAP), COPD/asthma, anemia in chronic kidney disease (CKD), stroke (SAH/prevention of vasospasms), primary biliary cirrhosis (PBC), oral contraception.
Medical devices: LVAD (left ventricular assistant device) 2 different devices, comfort drops against dry eyes, clinical thermometer, heel spur, special knife in vitroretinal surgery, device for closure of ASD/PFO, stent system in coronary artery lesions, mitral valve replacement; stent in femoropoplietal lesions (2 different dievices), neuromodulation in epilepsy, knee endoprosthesis.
Development of trial protocol, CRF and logistic plan; project management, training of investigators and partial monitoring of a neurological trial (multiple sclerosis, 120 centers)
Writing plans for drug monitoring for e.g. antidepressive medication, asthma drugs, homeopathic drug against otitis media
Assistance in development of the trial protocols, CRFs and trial reports for various medical devices (clinical thermometer, eye drops, lens implantation, heart deficiency NYHA IV, heel spur syndrome treatment with extracorporal shock-wave, device for closure of PFO)
Support in EC submissions including adaptation of Informed consent according to regulatory requirements, and including translation check.

Training:
Training and supervision of various employees in monitoring or project assistance in clinical research (ca. 30)
Lecturer and examiner for Pharma-Akademie, Bremen: CRA education including final examination
Free-lance lecturer for pharmaceutical companies and study sites: all items of interest concerning clinical research and drug development, monitoring qualification, conflict management, communication and soft skills, application training, study site logistics, GCP training for investigators and study nurses (medicinal products/medical devices).

Quality assurance:
In-house audits of trial protocols (about 30), CRFs (about 35) and clinical trial reports (about 50) for correspondence with SOPs and to check logic, plausibility and scientific validity (above all: phase I III trials for heart deficiency, hypertension, diabetes mellitus, depression, various eye diseases and other indications of internal medicine
On site audits (about 20 for phase III studies at investigators sites)
4 system audits (sponsor, other CROs), 10 x preparation of sponsors/regulatory audits at investigators sites

Medical writing:
Writing or reworking of various Standard Operating Procedures, mainly for Clinical Research
Translation of a brochure concerning drug development and clinical research/assistance in the translation of the ICH brochure (English into German)
Translation of various medical papers from English into German
Writing of information leaflets and information for health professionals for varying eye drops
Writing of a SPC (Specific Product Characteristic) for a calcium antagonist
Implementation of a proof-reading system for all print products of a pharmaceutical company
Answering questions (from physicians, pharmacists, patients) concerning a prescription-only drug for hair growth
Writing of a clinical trial reports (e.g. herbal antidepressive drug, heart deficiency)
Adverse Event Reporting (narratives of about 120 AEs/SAEs concerning a neurological study)

Special knowledge:
Computer literate (very good in Windows, Excel, Power Point).
Excellent knowledge of GCP (Good Clinical Practice), ICH-Guideline, MPG (German law for medical devices) and Drug Development, certificate as Training specialist for clinical research (Fachreferent Klinische Forschung)
German mother tongue, fluent in written and oral English language (about 60-70% of my duties are performed in English), oral French: good; written French: moderate
Broad working experience with various pharmaceutical manufacturers, central laboratories and CROs (mainly international)
Very good abilities in communication, presentation/moderation and motivation psychology