Objective: Clinical Research Associate
Established clinical research coordinator with over 7 years of experience in clinical research and a medical background
Professional Skills
Strong knowledge and experience in conductive responsible clinical research (industry and academic)
Performed Site Qualification Visits/Pre Study Visit working with an American CRO to ICH-GCP guidelines
During the Site Qualification Visits has evaluated potential clinical facilities and clinical research teams for performing a clinical research trial for a medical device related to orthopedic surgery
Working actively with REB and all related authorities
Strong knowledge and experience in patients’ consenting for the clinical research trials and observational studies
Strong knowledge Tri-Council Policy and Ethical Conduct for Research involving Human Subjects
Strong knowledge of GCP and HC guidelines for conducting of clinical research
Conducting and maintaining several randomized clinical trials simultaneously
Medical background
Maintaining consistent data entry to related data bases
Direct experience in transcribing source data in electronic case report forms (eCRFs) and EDC of various platforms, especially strong knowledge in Medidata Rave and InForm data bases; maintaining all related source documents and CRFs
Processing and shipment of blood/urine/bone marrow samples
Adverse and Serious Adverse Events monitoring and reporting
Site preparation for the regular monitoring and audit visits
Working with different types of IVRS/IWRS
Conducts pre-testing and administers questionnaires or other data collection tools
Planning, implementing and coordinating all aspects of data collection and source documentation, as per ICH/GCP guidelines, identifying problems using assessment skills and reports any abnormalities to relevant authorities
Executing study-related administrative tasks, such as collection of regulatory documents, ethics submissions, etc. Thoroughly assesses study-related literature
Conducting telephone and/or clinical recruitment interviews to collect data using established criteria
Coordinating patient visits schedule as per study protocol, and executing all aspects of study visit (e.g. assessment, adverse events, monitoring safety, medication, questionnaires, sample collection processing and shipment of samples according to clinical protocol)
Proven ability to multi-task in clinical and research environments
Experience in hiring, training and supervising summer research students/interns and liaises with sponsor and regulatory bodies for monitoring/audits
Computer skills: Microsoft Office including Word, Excel, Access, PowerPoint and Outlook
Patient service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds
Able to work under pressure with diligent and constant attention to detail
Great interpersonal skills and problem-solving skills
Therapeutic areas:
Neuroradiology and neurosurgery (aneurysms and AVMs)
Dermatology
Oncology
IVF
Work Experience
Clinical Research Coordinator
Stronach Regional Cancer Centre Curent
Clinical Research Associate/Coordinator 2016 – May 2017
Boston Biomedical Associates
Clinical Research Data and Regulatory Coordinator 2014 - 2016
University Health Network, DMOH
Clinical Research Coordinator 2012 - 2014
Toronto Dermatology Centre
Clinical Research Study Assistant July 2011 - June 2012
Toronto Western Hospital, UHN
Research Assistant (Volunteer) January 2011 - June 2011
Toronto Western Hospital, UHN
Intern July 2010 - September 2010
Princess Margaret Hospital, Ontario Cancer Institute
Previous Work Experience
Instructor (College for Dental Assistants/Medical Secretary Programs) Sep 2004 – Sep 2006
Dentist (Israel) May 2000 – Jun 2006
education and professional development
Clinical Research Association of Canada, Certificate December,2013
Clinical Research Coordinator (CRC) Diploma, Sep. 2009 – Jun 2010
Oxford College,
Clinical Research Program, Post-Graduate Diploma, Toronto
A full time, comprehensive CR program consisting of 9 months of theory followed by 3 months of clinical placement
Certificate in Tri-Council Policy Statement (TCPS) January 2010
Oxford College
Doctor of Dental Medicine (DMD) Graduated Jun 1995
Donetsk State Medical University, Ukraine
REFERENCES
Available upon request