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Clinical Research Associate

Location:
Edinburgh, Edinburgh, United Kingdom
Posted:
October 15, 2016

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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.



Contact this candidate