Kaitlyn Cyr is seeking a position and has over 5 years of experience in clinical research regulation and quality assurance. She currently works as a Regulatory Assistant at Yale University managing over 80 cancer clinical trials and ensuring compliance. Previously she has held roles in quality assurance and as a research assistant for phase one oncology clinical trials. She is detail oriented with strong organizational skills and experience adhering to regulatory guidelines.

1. Kaitlyn Cyr
14 Elizabeth St., Apt. 2
Branford, CT 06405
T 860 324-1114
kaitlyn.cyr92@gmail.com
S U M M A R Y
Extremely detail orientated with ceaseless dedication and commitment to deadlines, data
analysis, and professionalism. Always looking to improve and perfect existing processes with
forward thinking results and realistic goals. Continuously striving to perform to the utmost
quality and performance each day conforming to changing priority tasks as needed.
P R O F E S S I O N A L E X P E R I E N C E
Yale University, Yale Cancer Center November 2015 – Present
Regulatory Assistant- Hematology and Pediatric Oncology Clinical Trials November 2015-
present
• I review, analyze, and manage roughly 80 cancer clinical trial studies.
• Begin the start up process of a study by preparing the necessary applications to be
reviewed by Yale’s Protocol Review Committee.
• Prepare consent and assent forms based on the information in the protocol that will be
given to patients for their care.
• Prepare Institutional Review Board (IRB) submission applications for numerous IRB
groups such as WIRB, CIRB, BRANY, and Yale’s own Human Investigation Committee
(HIC).
• I work closely with pharmaceutical companies (sponsors) to process start ups, protocol
amendments, consent changes, and study closures in a timely fashion adhering to the
University’s policies and deadlines.
• Consistently comply with GCP, FDA, and HIPAA regulations.
• Participated in a working group to help modify a guidance document that better illustrates
our amendment process.
• Report patient adverse events should it meet the criteria for reporting to the IRB of record,
sponsor, or FDA.
• Regularly work with physicians, clinical research coordinators and assistants, and IRB
analysts to get what ever applications approved.
• Aid in preparing for internal audits, sponsor audits, sponsor monitoring visits, and
potentially FDA audits should they request a visit.

2. Research Assistant - Phase One Oncology Clinical Trials April 2015 - November 2015
• Assist the Regulatory Assistant with gathering signatures and regulatory documentation for
specific phase one cancer clinical trial studies.
• Prepare for sponsor Site Initiation Visits, monitoring visits, sponsor close out visits, and
internal audits for all phase one studies.
• Communicate on a daily basis with different sponsors and monitors to gather information
they request.
• Prepare regulatory documents for phase one protocols quickly and efficiently.
• Reconcile training documents, delegation of authority logs, in addition to maintaining a
proper file source for each phase one trial.
• Log, file, and have the principal investigator review safety reports for open study drugs.
• Experience with using OnCore and the Coeus systems at Yale.
• Conduct trainings for new research assistants on our core competencies.
• Have advanced working knowledge of research assistant core competencies.
Scapa North America, Windsor CT November 2011 – April 2015
Quality Assurance Technician - Second Lead
• Assist First Lead Technician in ensuring products get tested and shipped, documentation,
investigation, and other technician duties.
• Train new technicians on all protocols.
• Create new or update out dated protocols and present it to managers for approval.
• Test and document finished products to confirm products fall within the customer
specifications.
• Identify nonconforming products and conduct retests for all products which do not meet
predetermined customer specifications.
• Perform daily audits on production personnel and all documented product reports.
• Perform root cause analyses and investigations for all nonconforming products. Create
analysis reports and present to management as needed.
• Maintain the electronic Safety Data Sheet database.
• In process of implementing a Kanban system for all quality materials.
Research and Development Technician
• Organized, reviewed, and categorized incoming Safety Data Sheets publishing them for
the company to ensure safe handling of hazardous materials.
• Assisted in the development of the electronic Safety Data Sheet database.
• Preformed required testing to improve existing products or help create new products.

3. • Prepared samples to be sent out to new or potential customers of newly developed or
improved material for evaluation by the customer.
Huntington’s Disease Research Clinic Intern June 2013 – December 2013
University of Connecticut Health Center Intern in the Department of Psychiatry
At The University of Connecticut Health Center, I was given the opportunity to intern under the
direction of Dr. Carolyn Drazinic in the Department of Psychiatry in her Huntington’s Disease
Research Clinic.
• I Worked closely with staff to prepare a new Institutional Review Board (IRB)/
Connecticut Institute for Clinical and Translational Science (CICATS) protocol for a new
research study the Huntington’s Disease clinic was seeking.
• While maintaining existing day-to-day workload I studied bimolecular processes including
stem cell growth/maintenance and other disease specific research techniques.
• Completed extensive and required training programs to further my understanding with the
research process for diseases and illnesses when in a clinical setting.
V O L U N T E E R W O R K / I N T E R E S T S
• Huntington’s Disease Society of America (HDSA): CT Affiliate Member, 2012 to present
• Huntington’s Disease Society of America CT Affiliate Chapter Social Network Manager,
2014 to current
• Alzheimer’s Association: Fundraiser, 2012
• Hartford Heart Walk (American Heart Association): Event volunteer, 2010 and 2012.
• Semi-fluent in sign language
• Safety Committee: Scapa North America, 2014 through April 2015.
E D U C AT I O N
Central Connecticut State University, New Britain, CT — B.S. Biomolecular Science (Graduate -
3.5 years)
University of Saint Joseph’s, West Hartford, CT - M.S. Biology with Graduate Certificate in
Emerging Infectious Diseases (Enrolled-Part Time, Online)
R E F E R E N C E S
Danielle Wanik, Lead Clinical Research Coordinator for Phase One Oncology Clinical Trials,
860-463-4258 (cell phone) or danielle.wanik@yale.edu
Barbara Banz, PhD, Postdoctoral Fellow at Yale University School of Medicine, 973-879-9931
(cell phone), barbara.banz@yale.edu