Kathleen Montgomery has over 10 years of experience in clinical research as a research coordinator, clinical research associate, and site assessment specialist. She has a Bachelor's in Genetic Biology and is a certified clinical research professional. She has managed multiple clinical studies across various therapeutic areas and ensured compliance with study protocols and regulations. She has also trained other clinical research professionals and mentored new CRAs.

1. Kathleen A. Montgomery, B.S., CCRP
9035 Brandenburg Lane • Lafayette, IN 47905
(260) 450-2655 • kathleen.a.montgomery@gmail.com
PROFILE
Knowledgeable Clinical Research Associate for medical device, oncology, and biologic research studies. Highly
motivated, detail-oriented professional with excellent communication skills. Able to manage multiple studies and meet
deadlines in a timely manner. Works well independently and in team settings. Effective trainer, mentor, and proven leader.
EDUCATION
Purdue University, School of Science, West Lafayette, IN May 2007
• Bachelor of Science in Genetic Biology, Minor in Spanish
EXPERIENCE
Horizon Oncology Research Feb. 2015 – Oct. 2015
Research Coordinator Feb. 2015 – Oct. 2015
• Opened 5 clinical studies, trained site staff on protocols, and created site-specific tools to ensure protocol compliance
• Discussed studies in detail with patients and consented patients for study participation
• Gathered detailed patient histories and entered clinical data in EDC
• Assisted in study and patient prep for two clinical sponsor audits
• Processed and shipped protocol-required lab samples and performed ECGs
Cook Research, Inc. (formerly MED Institute, Inc., a Cook Medical company) May 2007 – Feb. 2015
Site Assessment Specialist 2012 – 2015
• Created and implemented training plan for new site assessors as the subject matter expert
• Utilized excellent communication skills to initiate contact and discuss study objectives and requirements with
potential study investigators and research staff
• Traveled throughout North America to assess potential investigators and research staff to determine their ability to
successfully participate in clinical research studies
• Maintained detailed understanding of multiple study protocols across various clinical specialties (i.e., aortic and
peripheral vascular, cell-therapy, urology, endoscopy, women’s health, trauma, surgery, venous therapy)
• Updated site assessment procedures and develop new assessment standards to increase efficiency and compliance
• Compiled various assessment metrics to evaluate assessment timelines and site performance
• Maintained a working knowledge of applicable regulations including 21 CFR 312 & 812, ICH GCP, and ISO 14155
Clinical Research Associate Leader 2010 - 2012
• Revised and updated clinical SOPs and guidances
• Headed the Terminology Committee to ensure current documentation practices were consistent throughout the
clinical team and utilized standard global terminology
• Trained and mentored new CRAs
• Created and implemented a CRA training program for new CRAs based on principles of instructional design
• Organized and led study project team meetings
• Identified monitoring needs and coordinated monitoring efforts with field monitors
Clinical Research Associate 2007 - 2012
• Served as lead in-house CRA on 12 investigational or post-market clinical studies for aortic and peripheral vascular
devices, GI devices, and cell-therapy
• Assisted in the development of various study support documents and submissions to regulatory authorities, including
annual reports, protocols, CRFs, informed consent documents, and monthly sponsor reports
• Utilized excellent communication skills with clinical sites on a daily basis to ensure compliance with study protocol
and applicable regulations, timely data entry and query resolution, and maintenance of required study documents
• Remotely monitored studies via electronic data capture (EDC) system and query management

2. • Traveled to investigative sites for initiation meetings to train study personnel on the study protocol and EDC system
ACTIVITIES & TRAINING
SoCRA Certified Clinical Research Professional (CCRP) Sept. 2009-Present
CITI Certification – Biomedical Research & GCP Sept. 2014
NIH Protecting Human Research Participants Training Mar. 2015
Shipping of Category A and Category B Substances Training Mar. 2015
Medidata RAVE EDC Training Apr. 2015
Guest Speaker for Purdue Biology 393 Career Development Panel Spring 2009 & 2010
Guest Speaker for Purdue Biology 115 Professional Career Panel Fall 2009 & 2011
Vice President of Administration, Delta Delta Delta Sorority Spring 2006
Study Abroad in Madrid, Spain Summer 2005