June 2019 - at Present
As a SCRA I monitor Dermatolgoy and Neurology studies, performed a full range of CRA tasks including feasibility, pre-study, Initiation, Interim Monitoring, Closeout and co-monitoring visits. With my previous experience I also perform out of scope activities as preparation and submission of Annual Reports, provide trainings in MS Office environment and budget negotiation with sites. Clinical Study Experience Involved in: - Dermatolgoy Phase IIa - Neurology Phase II Responsibilities: - Poland (12 sites) - Study stages handled: Initiation, Monitoring, Closeout
May 2015 - April 2019
As a CLM I was responsible for a group of CRAs and CTAs to oversee their work in Oncology, Cardiology and Urology studies. I am responsible to ensure all CRAs are appropriately trained on all aspects of the study and implementing and overseeing the ICG-GCP and Study Oversight Plan in their country including co-monitoring and oversight visits or coordinating Data Verification Initiatives. I prepare templates of PIICs, translations of documents EN-PL, submissions to local Regulatory and Ethics Committee of all required study documents. I proactively identify potential or actual country related issues and work closely with study team to ensure timely and sufficient resolution. In addition I was responsible for managing and tracking the Study Country Level Budget Feasibility process and Country Monthly Reports. My responsibility matrix also includes negotiating of clinical trial agreements with sites and budget negotiation. Involved in: Oncology, Cardiology and Urology.
SCRA outourced to Bayer
October 2014 - April 2015
As a SCRA I monitored Cardiology and Oncology studies, performed a full range of CRA tasks including pre-study, Initiation, Interim Monitoring, Closeout and co-monitoring visits. Clinical Study Experience Involved in: - Cardiovascular studies: Heart Failure Phase 3 - Heamatology Responsibilities: - Poland (4 sites) - Study stages handled: Initiation, Monitoring, Closeout
May 2011 - September 2014
As a CRA/CRAII I monitored Cardiology, Oncology and Neurology studies, performed a full range of CRA tasks including pre-study, Initiation, Interim Monitoring, Close-out and co-monitoring visits. Clinical Study Experience Involved in: - Oncology studies: Prostate Cancer, Leukemia - Neurology: SM - Cardiovascular: Heart Failure Responsibilities: · Oncology 4 sites, Neurology 3 sites, Cardiovascular 4 sites.
May 2006 - April 2011
at Wyższa Szkoła Mazowiecka
2006 - 2009 (3 years) Województwo Mazowieckie
Marketing and Management
at Politechnika Białostocka
1997 - 2003 (6 years) Województwo Podlaskie