BERENIKA KASPRZAK, M.Sc, B.Sc
Bilston, EH25 9SL, Midlothian,
E-mail: tdyask@r.postjobfree.com
Telephone: +44-745*******
PERSONAL STATEMENT
With a Masters in Medical Biotechnology and more than 5 years of international experience in science and clinical research, I am looking to further my career in clinical research. I am proactive and very hardworking. I work well in a team and independently. My core skills are: attention to detail, goo organization and prioritization of tasks, working under pressure and to tight deadlines.
KEY SKILLS AND EXPERIENCE
-Adhering to Regulatory and Legal requirements i.e. GCP, ICH Guidelines
-Involvement in multi-centre and global clinical Phase I - IV trials in oncology: breast, colorectal, gastric cancers; COPD, AML
-Conducting start-up, routine and close-out visits
-IT skills: Microsoft Office, Go to meeting, Skype, Statistics (Statistica, Graph Pad)
-Therapeutic areas: autoimmune diseases, COPD and oncology
-Complex administrative support of clinical trials
CAREER HISTORY
CRA, NHS National Services Scotland, Edinburgh (UK) Dec 2015 - present
Key areas of responsibility:
-Manage site processes and monitoring activities across the Scottish Clinical Trials Research Unit (SCTRU) trials portfolio.
-Perform source document verification and case report form review
-Ensure that trials are conducted in accordance with the monitoring plan, trial protocol, trial-specific processes and systems, SOPs, regulatory and ethical requirements and ICH-GCP
-Perform regulatory document review
-Conduct study drug inventory
-Co-ordinate and develop SOP for monitoring
-Set up systems to support remote and centralised monitoring to GCP and current legal/regulatory standards.
-Support the Clinical Trials Service Manager, Principal Trial Managers and project teams.
CTA, Chiltern International, Edinburgh (UK) Oct 2012 – Dec 2015
Key areas of responsibility:
-Tracking and collating of project information; distribution of invoices.
-Establish/maintain TMF filing plan liaising with PM and study team.
-Preparation of status reports, trackers for distribution to sponsors and vendors.
-Organising and taking minutes for project team meetings.
-Assisting with the organisation of Investigator Meetings.
-Attending CRA and Study Activate Specialist training workshops.
-Conducting on site and remote monitoring visits
-Preparation of IP release checklist
-Arrange project training, record certificates and grant access to study systems.
-Management of feasibility recruitments.
Assistant, Research Center Borstel (Germany) Jan 2012 – Oct 2012
Research field: IL-15/IL-15Rα as potential target for modulation of autoimmunity in
Experimental Autoimmune Encephalomyelitis model.
-Isolation, purification, culture and stimulation of murine primary cells (CD8+ T, DCs).
-Multi-colour flow-cytometrical analysis of complex primary leukocyte populations.
-Analytic biochemistry assay - enzyme-linked immunosorbent assay (ELISA).
-Light microscopy.
CTA, ClinStart Poznan (Poland) Dec 2010 – Jan 2012
Key areas of responsibility:
-Monitoring activities: CRF page preparation, tracking and onward distribution
-Collection and tracking of regulatory documents for submission to ethical committee
-Verification of IRB/EC approvals, collection and tracking of regulatory documents
-Assistance with protocol deviation tracking and adverse event reporting
-Updating status database (CV, record tracking) and preparation for client review
VOLUNTARY WORK
-English-Polish translator for Poznan International Fair 2007 – 2010
Voluntary work at One World Association, SCI, Italy Castagneto Po
EDUCATION, QUALIFICATIONS and WORK RELATED TRAINING
-2014, John Hopkins University
Distance Learning, Design and Interpretation of Clinical Trials
-2013, English certificate, Scottish Qualifications Certificate SQA
-2012 Research Center Borstel, Department of Immunology and Cell Biology Germany
Research field: IL-15/IL-15Rα as a potential target for modulation of autoimmunity in Experimental Autoimmune Encephalomyelitis model
-2009 – 2011 Poznan University of Medical Sciences
MSc Medical biotechnology; Thesis: Lymphocyte immunophenotype composition in acute myeloid leukemia.
-2006 – 2009 Poznan University of Medical Sciences
BSc Medical biotechnology; Thesis: Toll-Like receptors in immunological response.
SCIENTIFIC INTERNSHIPS
-2011 Institute for Biomedical Technologies, University of Milan Bicocca (Italy)
Research field: Molecular pathways in cardiovascular diseases
-2010 Biomedical Centre, Department of Neuroscience, Uppsala (Sweden)
Research field: Preparation of Cre lines - BAC cloning
-2009 Poznan University of Medical Sciences, Department of Clinical Immunology
Research field: Evaluation of ploidity level in cells with flow cytometry (Poland)
SCHOLARSHIPS
-2011 The SmaRT Student Research Training Program at University of Milano Bicocca
-2010 Scholarship from the Uppsala University, Biomedical Centre (BMC)
-2010 Erasmus Internship, Uppsala University, Biomedical Centre (BMC)
ADDITIONAL INTERESTS and SKILLS
My first language is Polish. I am fluent in English, and also have a good understanding of written German. Full Driving licence.
Hobby: Cinema, swimming, running, theatre, travel, classical music.