Human Subject Research Resources
Professional Research Assistants
| University of Colorado Hospital | Children's Hospital Colorado |
I have a Master’s degree in Women’s and Gender studies and a Bachelor’s degree in Psychology and Women’s Studies. I have worked in human subject research for over 13 years in Canada and the United States. In Vancouver, Canada, I was a Research Assistant at the WHRI where I worked on women’s health research. When I moved to Colorado, I was accepted as a Senior Clinical Research Coordinator in Otolaryngology. I became a working supervisor for the researchers who worked at UCHealth and Children’s Hospital of Colorado. In this position I was a researcher on studies and a leader of the research department. Currently, I oversee 3 UCHealth and 2 Children’s Hospital of Colorado CRC’s and their projects.
Research Services Program Manager Phone: 303-724-9528 | |
University of Colorado Hospital |
I have a bachelor’s degree in Speech, Language, and Hearing Sciences from CU-boulder. I graduated from CU in 2017 and have spent the last several years working as an audiology technician. I have worked in the private practice setting, as well as most recently being a technician at the UCHealth audiology clinic here in Aurora. Outside of work, I am a total dog mom to my St. Bernard and spend most weekends doing videography with my fiancé.  Shaylene Denham Phone: 303-724-8465 |
I’m originally from Tunisia, a beautiful and warm country in North Africa. I hold a master’s degree in biological engineering and a bachelor’s in medical biotechnology. With over four years of experience in clinical trials and quality management, I’ve worked for a multinational European company specializing in testing cosmetics and personal care products. This field has been my passion for years, and I’m thrilled to expand my expertise into healthcare settings as part of the Department of Otolaryngology at the University of Colorado Anschutz Medical Campus. Outside of work, I love exploring new places, baking with my two wonderful kids, and engaging in community activities.  Yosr Doghri Phone: 303-724-6550 |
I started work as a Clinical Research Coordinator at the Dept of Otolaryngology on May 22, 2023. Originally from Nebraska, I moved to Colorado in 2014 to attend CU Boulder, where I obtained my BA in Speech, Language and Hearing Sciences and an SLP-A Certificate. After graduating, I conducted in-home behavior therapy and early intervention speech therapy until I made my way back to Audiology. I started as an Audiology Technician with UCH-A in 2020, then advanced to Project Coordinator in 2022. I live near Longmont with my husband and two wonderful dogs and I enjoy gardening, thrifting, baking, and cooking.
Phone: 303-724-8335 Lyndsay.Zimmerman@CUAnschutz.edu
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| Children's Hospital Colorado |
| I'm originally from Milwaukee, WI (yes, the accent still comes out on occasion), lived in the desert for 22 years and have been here in Denver since October 2023. I am thankful that Denver winters are a far cry from WI winters. I worked for a private-practice Rheumatologist who ran clinical drug trials. We had long-term safety studies that lasted over 16 years and short-term studies that lasted barely one month. We even had one study where we were the first to inject the investigational product in a human subject. After a short stint as a medication access specialist, I'm looking forward to working directly with patients again. As for what I enjoy doing outside of work, I'm a fan of baseball, small-venue concerts, local coffee shops and traveling.
 Kari Gorecki Phone: 720-777-5841 |
I was born and raised in Colorado having spent most of my life in Aurora where I went to school and graduated from the Community College of Aurora. I joined the University of Colorado Hospital in 2012 and spent the last ten years as the coordinator for the cochlear implant program at the UCH Department of Audiology. I enjoy travel and golfing when outside of the office.
Paul Hynes
Phone: 720-777-3570 |
| Lab CRC |
Phone: 303-724-0289
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All Research – Series OTO-100
All investigators taking part in research involving human subjects must train on all of Series OTO-100
- OTO 100 –Institutional Review Board (IRB) Oversight
- OTO 101 – Informed Consent
- Attachment A – Assessing Comprehension of Informed Consent
- OTO 102 – Recognizing, documenting and reporting Adverse Events
- OTO 103 – Research Team Training
- Attachment A – Training and Educational Program Compliance Form
- OTO 104 –Records Management and Retention
- Attachment A – Protocol Training Log
- Attachment B – Delegation of Authority Log
- Attachment C - Study Personnel Log
FDA-Regulated Research – Series OTO-200
All investigators taking part in IDE or IND research must train on Series OTO-100 and OTO-200
- OTO 200 – Investigational Drug/Device Inventory Management
- Attachment A – Device Disposition Log
- Attachment B – Drug Disposition Log
- OTO 201 – Subject Screening and Recruitment
- Attachment A – Screening and Enrollment Log
- Attachment B – Inclusion and Exclusion Checklist
- OTO 202 – Subject Management While On Study
- Attachment A – Medical History
- Attachment B – Physical Examination
- Attachment C – Concomitant Medications Logs
- Attachment D – Adverse Event and Intercurrent Illness Log
- OTO 203 – Quality Management and Corrective Action and Preventive Action Plans
- Attachment A – PI Involvement, Meetings, and File Review Plan
- Attachment B – CAPA Worksheet
Additional Standard Operating Procedures, as
applicable – Series OTO-300
Investigators must train to the SOPs listed in Series OTO-300 only when they apply
- OTO 300 – Document Development and Change Control
- Attachment A – Table of Modifications and Document Approval Form
- OTO 301 – Physical Gift Card Management
- Attachment A – OTO 301 Attachment A - Gift Card Tracking Form
- Attachment B – Gift Card Tracking Spreadsheet
- OTO 302 – Petty Cash Management
- OTO 303 – Electronic Gift Card Management
- Attachment A - Electronic Gift Card Tracking Form
Investigator Application for New Studies
Grant Opportunities
Grant Writing
Human Research Training Requirements
Institutional Review Boards
IRB
Office of Grants and Contracts
Optional Training
Regulations and Standard Operating Procedures
Statistics