I have been working in the field of clinical research since June 2001. In my previous appointments I have been responsible for all aspects of clinical monitoring in accordance with national drug and medical device laws, European directives, company SOPs, ICH-GCP, ISO 14155-1/2:2011 and FDA regulations (e.g. 21 CFR § 312).
I have been involved in the writing of study protocols, the design of CRFs, submissions to IECs/IRBs and regulatory authorities (throughout Europe), recruitment of investigational sites and in the support of clinical database validation programming.
In the last thirteen years I have participated as a CRA or Lead CRA in predominantly cardiological drug (phases II - III) and medical device studies but also in other indications like oncology. In the context of these I have attended numerous training sessions (e.g. general pharmacology, pharmacokinetics, ECG interpretation and disease management seminars). The mentioned studies were conducted in European countries either on both standard and special populations (e.g. elderly, renal or hepatic impaired patients).
In addition to the above, I have been responsible as a junior project manager for studies in the indications hypercholesterolemia and pulmonary hypertension. As part of my duties as project manager and Lead CRA I have successfully performed trainings of CRAs, and was involved in negotiations with third-party vendors and CROs.
Since April 2004, I have been working as a freelance clinical research consultant. I am responsible for in-house and on-site monitoring activities as well as for submissions to IECs/IRBs and regulatory authorities. Other services provided are: GCP and regulatory training, medical writing and in-house support to study-related activities. High-end computer and communication equipment is in place to guarantee 24/7 service and customer’s satisfaction.