Profile Objective & Highlights of Qualifications

Sound background in clinical research including successful completion of

postgraduate diploma and publications of MSDS reports for infectious
pathogens. I have demonstrated solid work ethics in promoting students in
their academic progress. Strong analytical skills from successful
completion of research project in Molecular Genetics and research in
project management.
. Demonstrated success in preparing relevant documentation and reviewing
clinical trials in accordance with Health Canada guidelines and
regulatory requirements (TPD, FDA, EMEA, ICH)
. Experience in adherence to Good Clinical Practices (GCPs), SOPs, and
study protocols
. Customer service oriented: Strong interpersonal and conflict resolution
skills from tutoring job
. Knowledge in research ethics board submission, processing regulatory
requirements of research involving human subjects
. Detail-orientated and able to multi-task in deadline driven environment
. Highly proficient in Microsoft office suite, internet research and Health
Canada data software
. Proved conscientious, dependable and adaptable to manage varying workload

. Proven initiative with well developed analytical, leadership,

organizational, prioritizations and time management skills
. In depth therapeutic and protocol submission knowledge in Clinical
Research
Relevant Work Experience
Biologist, 2010
Public Health Agency of Canada (PHAC),
Ottawa, ON
. Developed material safety data sheets (MSDS) for pathogens with
commitment to accuracy
. Worked effectively to conduct literature searches from targeted
research studies
. Conducted scientific literature searches via online and library resources
to update MSDS
. Used scientific support supporting the Human Pathogens Importation
Regulations and changes to these regulations, to prepare MSDS reports.
. Prepared MSDS reports by utilizing scientific support from the evidence-
based guidelines, and Human Pathogens Importation regulations
Clinical Research Intern, 2009
Health Canada, Biologics, Genetics and Therapies Directorate (BGTD),
Ottawa, ON
. Organized various project meetings, information site visits and
other research related events
. Reviewed PSUR and completed PSUR reports according to HC-TPD
policies
. Analyzed product monographs according to Health Canada guidelines
. Conducted risk assessments of adverse events from biological drugs

. Studied and prepared adverse event reports received from

international countries communicated
with sponsor for changes to be implemented
. Advised supervisor in relation to all serious adverse events
 . Examined protocol for Notice Of Deficiency (NOD) and provide
informational support
Education
Clinical Research, postgraduate diploma, 2009
Humber College, Toronto, ON
. Strong knowledge in Clinical Research methods including study design,
infrastructure, data management, study logistics, regulatory issues
. Sound understanding of scientific and ethical guidelines/regulations for
conducting clinical research, namely: ICH-GCP, PIPEDA, U.S. Code of
Federal Regulations
. Comprehensive knowledge of IATA shipping regulations and laboratory
procedures
. Specialized in courses in Product Development, Regulations and Guidelines
for Clinical Research, Recent Trends in Therapeutics, Scientific and
Technical writing, Biostatistical Methods, Clinical Project Management,
Organization and Monitoring of Clinical Trials

Molecular Biology and Genetics, BSc. (Hons), 2008

University of Guelph, Guelph, ON
Biotechnology Research, advanced college diploma, 2006
Seneca College, Toronto, ON
Other Research and Teaching Experience
Research Technician in Molecular Biology Lab, 2007
University of Guelph, Guelph, ON
. Monitored inventory of laboratory supplies and succeeded in reducing
waste of laboratory materials and led research team in experiment from
execution to completion
. Collaborated with team members to prepare papers for presentation and/or
publication
. Demonstrated multitasking abilities while handling a variety of roles and
projects simultaneously
. Evaluated significance of experimental findings by using various
statistical tests
Science Tutor, 2004-2006, 2008
Seneca College, Toronto, ON
. Tutored 600 university and college students in Math and Science
courses
. Trained 20 new tutors of diverse ethnic background in policies and
procedures
. Organized and designed innovative curriculum and outdoor activities
for approximately 50
elementary and high school students with emphasis on capacity building
References
Available upon request