Nadia M. Daniel, MSc.
Clinical Trial Specialist in Paediatric Oncology & Regulatory Affairs (GCP/Div5) at C17 Council- Claim this Profile
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Dutch Native or bilingual proficiency
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English Full professional proficiency
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Spanish Professional working proficiency
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Papiamento Full professional proficiency
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French Limited working proficiency
Topline Score
Bio
Credentials
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McGill Personal Finances Essentials
McGill University - Desautels Faculty of ManagementJan, 2020- Oct, 2024 -
Good Clinical Practice (GCP) - Clinical Research Associates/Coordinators
CITI ProgramFeb, 2022- Oct, 2024 -
Health Canada Division 5 - Clinical Research Associates/Coordinators
CITI ProgramNov, 2021- Oct, 2024
Experience
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C17 Council
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Canada
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Research Services
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1 - 100 Employee
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Clinical Trial Specialist in Paediatric Oncology & Regulatory Affairs (GCP/Div5)
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Jul 2018 - Present
Clinical Research Associate at C17 Council Edmonton, AB, CanadaThe C17 Council is an organization composed of the institutionally appointed heads of the sixteen paediatric haematology, oncology, and stem cell transplant programs across Canada. It represents the interests of children and adolescents with cancer and blood disorders. - Managed in-person & remote monitoring of 10+ Phase II/ III clinical trials in paediatric oncology for 15 hospitals across Canada from initiation to closeout. Submitted the required regulatory documents to Health Canada for clinical trials with investigational agents and off-label marketed drugs.
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Queen's University
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Canada
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Higher Education
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Clinical Trial Monitor in Adult Oncology (GCP/Div5)
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Dec 2016 - Jun 2018
Cancer Research Monitor at Canadian Cancer Trials Group, Kingston, ON, CanadaThe Canadian Cancer Trials Group is a cancer research cooperative group that provides unique expertise and infrastructure to conduct national and international multicentre Phase I-III cancer clinical trials aimed at improving the survival and quality of life of cancer patients across all cancer types.- Conducted Quality Control and Quality Assurance activities for 50+ IND and Phase III clinical trials in cancer research in Canada- Coordinated and participated in 30+ external audits and/or regulatory inspections in support of the overall quality control and assurance program CCTG.
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Clinical Trial Research Analyst (GCP/GLP)
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Oct 2015 - Dec 2016
Research Assistant at Kingston General Hospital, Kingston, ON, CanadaThe Division of Allergy & Immunology has a dedicated group of researchers under the direction of Dr. Anne K. Ellis, focused on the discovery and validation of new treatments for allergic rhinitis and is also seeking to identify potential biomarkers of future atopy via cord blood collection.- Developed the database for an Allergy Birth Cohort for association studies between umbilical cord blood predictors of atopy, which lead to 2 co-author publications. - Assessed allergen levels exposures during clinical trials for allergic rhinitis in the Environmental Exposure Unit for validation studies.- Trained new personnel on concepts of biosafety and equipment use.Publications:1. Kingston Allergy Birth Cohort (KABC); Exposome Characteristics and Parentally- Reported Respiratory Outcomes to Age 2 | TSpace Repository [Internet]. [cited 2020 Feb 14]. Available from: https://tspace.library.utoronto.ca/handle/1807/877122.North ML, Brook JR, Lee EY, Omana V, Daniel NM, Steacy LM, et al. The Kingston Allergy Birth Cohort: Exploring parentally reported respiratory outcomes through the lens of the exposome. Ann Allergy, Asthma Immunol. 2017 Apr 1;118(4):465–73.
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HAL Allergy Group
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Netherlands
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Pre-Clinical Development Analyst
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Jan 2015 - Sep 2015
HAL Allergy Group focuses on the diagnostic & treatment of allergies and contract manufacturing for the pharmaceutical development and production of batches for pre-clinical and clinical studies.- Characterized recombinant pollen peptides as building blocks for a self-assembling birch pollen vaccine delivery system. This work was presented at the he European Academy of Allergy and Clinical Immunology
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Quality Control Analyst - Biochemistry & Analytical Development
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Sep 2013 - Dec 2014
- Reviewed Quality Control data-entry reports and trained new personnel- Developed, improved and validated biochemical antibody-based assays
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Quality Control Analyst – Biochemistry
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Sep 2012 - Aug 2013
- Performed quality control lab testing of raw materials, intermediate- and end products for release and stability studies according to regulations - Analysed organic compounds using spectroscopic assays - Managed inventories and safety equipment for lab personnel
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Leiden University Medical Center
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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Research Laboratory Analyst – Airway Inflammation
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Nov 2013 - Apr 2014
Research at the Department of Pulmonology is focused on basic and translational research in Asthma and COPD, with a focus on the role of the lung epithelium in inflammation and remodelling.- Studied the effect of cigarette smoke on epithelial wound healing and tissue remodelling in the airways. This work led to 3 co-author publications Research at the Department of Pulmonology is focused on basic and translational research in Asthma and COPD, with a focus on the role of the lung epithelium in inflammation and remodelling.- Studied the effect of cigarette smoke on epithelial wound healing and tissue remodelling in the airways. This work led to 3 co-author publications
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Crucell
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Biotechnology Research
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1 - 100 Employee
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Quality Control Analyst - Stability & Release (GMP/GLP)
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Oct 2010 - Apr 2011
Crucell Pharmaceutical. Companies of Johnson & Johnson, Leiden, The Netherlands Crucell is a biotech company that specializes in the development of vaccines and biopharmaceutical technologies and has joined the Janssen Pharmaceutical Companies of Johnson & Johnson in 2011.- Tested the quantity, potency, purity and identity of drug substances, virus and antibody products using cell-based, analytical and spectroscopic assays- Carried out internal orders, purchases and sample requests Crucell Pharmaceutical. Companies of Johnson & Johnson, Leiden, The Netherlands Crucell is a biotech company that specializes in the development of vaccines and biopharmaceutical technologies and has joined the Janssen Pharmaceutical Companies of Johnson & Johnson in 2011.- Tested the quantity, potency, purity and identity of drug substances, virus and antibody products using cell-based, analytical and spectroscopic assays- Carried out internal orders, purchases and sample requests
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De Ruiter Seeds
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Farming
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1 - 100 Employee
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Quality Control Analyst – Microbiology (GMP/GLP)
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Oct 2009 - Sep 2010
De Ruiter Seeds-Monsanto, Bergschenhoek, The NetherlandsDe Ruiter specializes in breeding, producing and selling seed varieties for glasshouse cultivation of tomato, pepper, cucumber, eggplant and melon. De Ruiter was acquired by Monsanto in 2008.- Performed quality control for producing GMO seed varieties for glasshouse cultivation of fruits and vegetables. De Ruiter Seeds-Monsanto, Bergschenhoek, The NetherlandsDe Ruiter specializes in breeding, producing and selling seed varieties for glasshouse cultivation of tomato, pepper, cucumber, eggplant and melon. De Ruiter was acquired by Monsanto in 2008.- Performed quality control for producing GMO seed varieties for glasshouse cultivation of fruits and vegetables.
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Education
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2018 - 2023
University of Alberta
Doctor of Philosophy - PhD, Pulmonary Medicine, Alberta Respiratory Centre (ARC) -
2014 - 2014
Leiden University
Specialty within MSc. Biomedical Science, Science Based Business (SBB) -
2013 - 2015
Leiden University
Master of Science (MSc), Biomedical Sciences, Research -
2011 - 2012
Leiden University
Pre-Master, Biomedical Sciences -
2005 - 2009
Trent University
Bachelor of Science (BSc.), Biochemistry and Molecular Biology -
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High school Colegio Arubano, Aruba
Voortgezet Wetenschappelijk Onderwijs (V.W.O)
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