Kirstin McRaith
Chicago,IL
Summary
Motivated project coordinator senior with 5 years of clinical research experience and more than 2 years of management experience. Strong skills and knowledge of project management, regulatory compliance, clinical trials, and ICH/GCP guidelines. Holds bachelors’ degrees in biology and psychology and will graduate with a master’s in regulatory compliance with a specialization in clinical research in June 2024.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Project Coordinator Senior
Northwestern University, Feinberg School of Medicine
Chicago, IL
12.2022 - Current
- Manages two large NIH funded studies, the All of Us Research Program (AoURP) and Nutrition for Precision Health (NPH), across 3 clinical sites.
- Directly manages and tracks performance for 5 staff members
- Participates in study start-up activities and site initiation visits to ensure site activation for controlled feeding studies
- Reviews and edits regulatory documents for the CRO
- Negotiates with vendors, obtains quotes for clinic supplies, and helps manage the study budget
- Trains staff on how to use novel dietary assessment methods, monitor participant dietary adherence, and conduct mixed meal tolerance tests
- Developed site specific source documents, SOPs, and workflows
Research Study Coordinator Senior
Northwestern University, Feinberg School of Medicine
Chicago, IL
01.2021 - 09.2024
- Coordinated daily clinic operations of the All of Us Research Program across 2 clinical sites
- Responsible for supervising and onboarding junior staff
- Verified all study documents were up to date with current local, state, and federal guidelines.
- Conducted quarterly quality control checks to confirm staff adherence with study procedures in addition to complete and accurate source documentation
- Attended Mayo Clinic biobank meetings, identified and documented biospecimen quality issues at the site level, and worked with staff to correct the issue
- Documented, filed, and communicated all adverse events to the PI
Research Project Coordinator
Northwestern University, Feinberg School of Medicine
Chicago, IL
09.2021 - 12.2022
- Managed the All of Us Research Program across 3 clinical sites
- Provided direct supervision to research staff, delegated tasks, monitored staff progress, and supervised training
- Played a pivotal role in ensuring our team enrolled over 3,000 participants during year 5 to meet enrollment milestones set by the NIH
- Attended NIH site manager meetings, helped complete IPMC/NIH monthly and quarterly reports, and corrected site specific errors
- Managed all inventory, ordered study supplies, and tracked shipments
- Participated in hiring and interviewing over 10 research staff
Research Study Assistant
Northwestern University, Feinberg School of Medicine
Chicago Heights, IL
08.2019 - 01.2021
- Supported the clinical research team with the recruitment of study participants, data collection, and completion of study documentation for the AoURP
- Collected medical history and reviewed medical records to determine participant eligibility
- Obtained informed consent, administered questionnaires, and interviewed participants
- Obtained participant physical measurements, vital signs, and biospecimens
- Abided by HIPAA to maintain confidentiality of all sensitive information
Research Assistant
University of Missouri System
Columbia, MO
10.2018 - 05.2019
- Investigated the cognitive processes that underlie episodic memory
- Studied normal cognitive and neural function of healthy individuals to understand how memory is impaired by brain injury, neurological disease, and aging
- Independently ran studies with participants and used MATLAB to record participant responses
- Screened participants, obtained informed consent, and analyzed data
Education
Master of Science - Regulatory Compliance
Northwestern University
Evanston, IL06-2024
Bachelor of Science - Biology; Psychology
University of Missouri - Columbia
Columbia, MO05-2019
Skills
- Project management
- Good Clinical Practice (GCP)
- Regulatory Compliance
- Quality Systems
- Systems/Applications: REDCap, EPIC, Dexcom Clarity, ActiLife, ActiSync, CentrePoint, ASA24, DHQ3
Certification
CITI Program: HIPAA, GCP, and Human Subjects Research, Basic Life Support (BLS), Adult Mental Health First Aid, Northwestern’s Safe Shipping of Biological Materials and Dry Ice
Timeline
Project Coordinator Senior
Northwestern University, Feinberg School of Medicine
12.2022 - Current
Research Project Coordinator
Northwestern University, Feinberg School of Medicine
09.2021 - 12.2022
Research Study Coordinator Senior
Northwestern University, Feinberg School of Medicine
01.2021 - 09.2024
Research Study Assistant
Northwestern University, Feinberg School of Medicine
08.2019 - 01.2021
Research Assistant
University of Missouri System
10.2018 - 05.2019
Master of Science - Regulatory Compliance
Northwestern University
Bachelor of Science - Biology; Psychology
University of Missouri - Columbia
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