Clinical Research Assistant

Hesham Bakr

****-********** ***** *******, ** M*C 5L9

416-***-**** / **************@*******.***

PROFESSIONAL HIGHLIGHTS

Two years experience as Research Assistant and Research Analyst 1 at the Center for Addiction and Mental Health CAMH Strong knowledge of regulatory requirements concerning clinical trials Extensive knowledge of drug, device development process, human path physiology and diseases. Significant experience in: medical history, vital signs, phlebotomy and E.C.G Clear understanding of clinical trial protocols, regulatory affairs (health- care), I.C.H -G.C.P, US F.D.A regulations, R.E.M.S, case report forms, ADE and, informed consent form Knowledgeable in determining study site feasibility, the study protocol, development of study budgets (Cost Estimation), I.R.B requirements, study visits, transcribe source information onto Case Report Forms C.R.F Bachelor and Master's degree in the field of medicine.

WORKING HISTORY

1. Research Analyst at Center for Addiction and Mental Health- Toronto, Ontario November, 2015 – May, 2016

Informed Consent of Subjects/ Assessment for Participants CRF Completion/ Submission/Correction Concomitant Drug Accountability/Dispensing Subject Recruitment/Education Submitting Adverse Events Shipping Laboratory Specimens Performs study procedures Clinical Lab Services/ Spinning/ Haematocrite/ Deep freezing -80 Degree Submitting Serious Adverse Events to Regulatory (Health Canada and REB) Data Analysis / Extraction/ Tabulation Administration/Financial/ Contracts Regulatory Submission/ Very familiar with Health Canada for Clinical Trials.

Actively conducted the following studies at CAMH: Exploring Occupancy of the Histamine H3 Receptor by BP1.3656B and BF2.649 in Humans Using PET Impact of Nicotine Metabolism on Brain Dopamine Transmission Testing the PPAR Hypothesis of Nicotine Dependence in Humans: Embroilment as a Novel Treatment for Tobacco Addiction Exploring Occupancy of the Dopamine D3 Receptor by BP1.4979 in Humans Using PET

2. Placement at Lambda Therapeutic Research Toronto, Ontario (2months) 2013 E.C.G, phlebotomy, drug, alcohol screening, centrifugal and general medical Laboratory techniques

OTHER EXPERIENCES

Handled projects in cost estimation, project management for clinical trial study, class 2 new medical devices application, labeling of medical devices and presentations for epidemiological study.

EDUCATION

Post-graduate diploma of clinical research Toronto, Ontario 2014 Project management O.S.L.T from Huber College, Toronto 2015 Medical laboratory technician diploma (Anderson College), Toronto 2013

CERTIFICATES AND COURSES

● Best G.C.P on PET studies C.A.M.H Toronto 2015 ● Health Canada Division 5 - drugs for clinical trials involving human subject 2015 ● G.C.P. - Regulated Studies (Drugs, Device, and N.H.P) ● Responsible Conduct of Research- Life Science 2015 ● Ti Council Policy statement T.C.P.s 2013 ● Certificates of Clinical Pharmacology, Clinical Safety Assessment, Medical Devices, Post Marketing compliance for safety monitoring and NIH-plain language training 2104 ● Career in clinical research from C.R.A.C 2014 ● Ontario Society of Medical Technology certificate O.S.M.T 2013 ● First aid/CPR training from Red Cross Canada, T.D.G 2012

REFERENCES:

Bernard Le Foll, MD PhD MCFP Laureate of the French Academy of Medicine Medical Head, Addiction Medicine Service and Medical Withdrawal Service, Ambulatory care and Structured Treatments, CAMH. Head, Alcohol Research and Treatment Clinic, Addiction Medicine Services, Ambulatory Care and Structured Treatments, CAMH. Head, Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, CAMH. Professor, Departments of Family and Community Medicine, Pharmacology, Psychiatry and Institute of Medical Sciences; University of Toronto. Center for Addiction and Mental Health 33 Russell Street, Toronto, Canada M5S 2S1. Tel: 416-***-****, ext. 34772 Fax: 416-***-**** *******.******@****.**

Patricia Di Ciano, PhD Project Scientist Center for Addiction and Mental Health 33 Russell St, Toronto, M5S 2S1 Tel: 416-***-**** x34002 ********.*******@****.**

Linda Cock, Professor in Anderson College *****@***************.***

Irene Russell, Professor, O.S.L.T, Project Management at Humber College Toronto, Canada Area Higher Education *****.*******@******.**

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