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 3 Children’s Hospital of Colorado CRC’s and their projects.
Supervisor and Senior Clinical Research Coordinator Phone: 303-724-9528 Kristi.Englefolchert@CUAnschutz.edu | |
University of Colorado Hospital |
I graduated in May from the University of Colorado Boulder with a degree in Speech, Language and Hearing Sciences. I’m from Louisville, Colorado and like to ski and hike in my free time.
Avery Allen Phone: 303-724-6550Avery.Allen@CUAnschutz.edu |
Quin graduated from CU Boulder in 2022 with a double major in Psychology and Speech, Language, and Hearing Sciences. She grew up in Seattle, and enjoys running, skiing, and surfing her in her free time. Quin is aspiring to be a Clinical Psychologist, with her own practice in the future.
Quin Axelson |
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 |
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| Children's Hospital Colorado |
Hi everyone! My name is Paula Mariel Abila, but I go by Mariel. My family immigrated from Argentina when I was very young. We decided to plant our roots here in Colorado where I have stayed for most of my life. It was here where I learned how to snowboard, fell in love with hiking and the outdoors, met my fiancé, and got my Bachelor of Science degree. I went to school at Colorado Mesa University in Grand Junction, CO where I realized I wanted a career in medicine. I’ve been in the clinical research field for about two years, but excited to be a part of the Anschutz medical campus now and broaden my knowledge and expertise in the Otolaryngology department.
Mariel Abila |
I am from Houston Texas and graduated from Texas A&M in May 2021 with a BA in biology and a minor in business. I've worked a variety of jobs growing up from Smoothie King to 1-800-GotJunk to performing translational oral cancer research, and I am excited to now be in a clinical research position. In my free time, I enjoy working out and playing with my cat and I hope to get into hiking soon!
Austin Zhu |
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| Lab CRC |
Landen Mayher
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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
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