Dynika St Omer has over 5 years of experience as a clinical research coordinator and medical laboratory technician. She currently works as a clinical research coordinator for the Obstetrical Maternal Newborn Investigations research group at the Ottawa Hospital Research Institute. She oversees multiple clinical trials and studies at two Ontario sites. Her responsibilities include participant recruitment, obtaining consent, data collection, sample collection and processing, regulatory documentation, and study coordination. She has experience coordinating trials in dermatology and obstetrics/maternal health. Dynika strives to maintain high professional standards through continuing education and certifications in good clinical practice and research ethics.

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Dynika St Omer
Certified Clinical Research Coordinator, CCRP
&
Medical Laboratory Technician, MAL/T
Dynika.st.omer@gmail.com
613-297-3813
Clinical Research Coordinator with the Obstetrical Maternal Newborn Investigations research group at
the Ottawa Hospital Research Institute
Current Employment & Volunteer Positions
Dec 2012- present Clinical Research Coordinator, CCRP
Obstetrical Maternal Newborn Investigations (OMNI)
Ottawa Hospital Research Institute
May 2014- present Volunteer
Rideau Valley Wildlife Sanctuary
Sept 2011- present Volunteer
Ottawa Humane Society
Education
2013 Certification Certified Clinical Research Professional(CCRP)
SoCRA – Society of Clinical Research Associates
2010 – 2011 Diploma Medical Laboratory Technician (MLA/T)
Everest College, Ottawa,Ontario
2005 – 2007 Diploma Veterinary Technology
Northern college, Haileybury, Ontario
Past Employment & Positions
2011 – 2012 Clinical Research Assistant- Dermatology
Private practice, Dr. M. Robern, Ottawa,Ontario
2011 – 2012 Venipuncture/ECG Technician
Queensway Carleton Hospital, Ottawa,Ontario
2010 – 2011 Veterinary Assistant
Merivale Cat Hospital, Ottawa,Ontario

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Licensure & Memberships
2013 – Present Society of Clinical Research Associates (SoCRA), Member
2011 – Present Ottawa Society of Medical Technologists (OSMT), Member
Research Tasks & Responsibilities
Clinical trial duties with participants:
Subject identification & recruitment ▪ Consenting to trial as per ICH-GCP guidelines ▪ Randomizing
participants ▪ Collection of basic medical history information ▪ Carry out trail procedures and study visit
procedures ▪ AE/SAE/CON MEDS information ▪ Data entry ▪ Preparing for monitoring visits ▪ Screening
and enrollment log maintenance ▪ Collection & processing biological samples ▪ Shipping study biological
samples
Research Ethics Board duties:
Currently oversee clinical operations for multiple investigator led studied at two Ontario sites ▪
Completing Research Ethics Board applications ▪ Study start up procedures ▪ Preparing consent forms and
other study information documents to reflect protocol/SOP/ICH-GCP requirements ▪ Maintenance of
regulatory documents/binders ▪ Annual renewals of ongoing studies ▪ Submission of Protocol
Amendment documents ▪ SAE reporting
Physical assessment skills:
Venous blood draws ▪ ECGs ▪ Manual and automatic blood pressure ▪ Temperature ▪ Weight
Certification & Professional Development
Oct 2013 Certified Clinical Research Professional(CCRP)
SoCRA- Society of Clinical Research Associates
Mar 2013 TDG- Training for the Transportation of Dangerous Goods Certification
Ottawa Hospital Research Institution
Dec 2012 Division 5 compliance regulations
Ottawa Hospital Research Institution
Dec 2012 ICH-GCP - CITI Course in the Protection of Human Research Subjects
Web based training
Dec 2012 WHMIS
Web based training
Jan 2012 Good Clinical Practice Training (Version 1.1): Health Canada Food and Drug
Regulations & ICH Harmonized Tripartite Guideline for Good Clinical Practice
Probity Medical Research
Mar 2011 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
Ethics (TCPS 2: CORE) Certificate Panel on Research Ethics,Web-based
Training

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Mar 2011 Protecting Human Research Participants Certificate the National Institutes of
Health (NIH) Office of Extramural Research,Web-based Training Course
Research Activity & Clinical Trials - Dermatology
1. 2011 – Pfizer: A phase 3, multi-site, open-label study of the long term safety and tolerability of 2 oral
doses of CP-690,550 in subjects with moderate to severe chronic plaque psoriasis
2. 2011 – Pfizer: A phase 3, multi-site, randomized, double-blind, placebo-controlled, parallel-group
study of the
efficacy and safety of 2 oral doses of CP-690,500 in subjects with moderate to severe chronic plaque
psoriasis
3. 2011 – Celgene: A phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and
safety study of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis
4. 2011 – Celgene: Long-term safety extension study of apremilast (CC-10004) in subjects who
completed the treatment phase of the extension study CC-10004-PSOR-005E
5. 2012 –AMGEN: A phase 3 study to evaluate the efficacy and safety of induction and maintenance
regimens of brodalumab compared with placebo and ustekinumab in subjects with moderate to severe
plaque Psoriasis: AMAGINE-2
6. 2012- Eli-Lilly: A phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-
to-Severe Plaque Psoriasis
Research Activity & Clinical Trials – Obstetrical Maternal Newborn Investigations (OMNI)
1. 2013 – FACT: Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical
Trial- A randomized, double-blind, placebo-controlled, Phase III, international multi-centre study of 4.0
mg of Folic Acid supplementation in pregnancy for the prevention of preeclampsia. Coordinator
2. 2013 – NBS: Newborn Screening Project: The goal of this study is to measure and compare parental
responses to different educational messages about newborn screening (NBS). Assistant
3. 2013 - NEXT: Non-Invasive Chromosomal Examination of Trisomy Study, multi-center, prospective,
case-controlled study is to compare the Ariosa Harmony™ PrenatalTest for triasomy 21 detection with a
standard first-trimester prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG[β-
hCG] or total hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening)
in a general screened population. Coordinator
4. 2013 - 17p-FU-004 - A Prospective, Noninterventional Follow-Up Study of Children Aged 23-25
Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/ml, or Vehicle
for Prevention of Preterm Birth (17P-FU Study) Coordinator
5. 2013- MiTy: Metformin in Women with Type 2 Diabetes in Pregnancy Trial, Multicentre, double
masked, randomized placebo-controlled trial of Metformin or placebo in addition to their usual insulin

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regimen, in women with type 2 diabetes in pregnancy (or undiagnosed type 2 diabetes as defined in
‘Inclusion criteria’), between 12 and 22 weeks gestation. Coordinator
6. 2013- PEGASUS: Personalized Genomics for prenatal Aneuploidy Screening Using maternal blood,
the study hypothesis is that new genomics- based non-invasive methods using fetal-DNA in maternal
blood during pregnancy can be more effective than current prenatal screening methods for fetal
aneuploidy. Coordinator