Project Manager/Senior CRA
Since September 2015
Study Authorization Associate II
Since September 2011
My job contains study start up phase of different kind of clinical trials. I have done a lot of budget and contract negotiations. I have experience also from feasibilities, EC and RA applications, drug release, CDP packages, label reviews and arranging teleconferences. At the moment I have been writing or reviewing patient documents for all around the World.
Lead CRA/Senior Clinical Research Associate/ Regulatory Affairs Officer
February 2008 --- August 2011
I took care of clinical trials from the beginning of the trials to the end of them. I have done phases II-IV, and I take care of contracts and budgets too. I did much internal and external trainings and education sessions. I also educated junior CRAs. I have also experience as a Lead CRA for a group of CRAs (Finland, Estonia). My experience contained cardiology, intestinal, psychiatry and neurology studies. Some cancer studies too. I have done EC and CA applications and submission packages, involved with contracts and budgets, done monitoring and site management, site closing etc. I also worked with regulatory affairs doing and writing MA applications, variations, renewals and other maintenance work with marketing drugs.
Clinical Research Associate (CRA)
September 2006 --- January 2008
I got a lot of experience of monitoring clinical trials, I also started studies and closed them. I took care of everything by myself from the beginning of the studies to end of them, also budgets and contracts. A lot of traveling.
Biology and Chemistry Teacher
August 2004 --- July 2005
Teaching biology and chemistry for teenagers between 13-16 years. Educating, teaching, parenting children and teenagers. Arranging many visits to local biotechnology companies, visits to forests and strands, doing a lot of chemical tests and procedures with pupils.
January 2000 --- January 2003
I was doing research work with microbiology and plant extracts/ essential oils, doing chemical GC/MS analysis, teaching students, doing gene analysis, supervising student's thesis works in Department of Pharmacy.
Professional biology and chemistry teacher in Pedagogigs from University of Helsinki in 2004
Licentiate of Pharmacy in Pharmacy from University of Helsinki in 2003
Master of Sciences in Biology, Chemistry, Biochemistry, Genetics, Zoology, Plant Physiology, Statistics, from University of Oulu in 1999