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Clinical Research Data Entry

Location:
Richmond Hill, Ontario, Canada
Posted:
February 20, 2018

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Resume:

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



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