Kirstin McRaith
Chicago,IL
Summary
Clinical Research Professional with 7+ years in IND, IDE, and observational studies in cardiovascular, nutrition, and genomic fields. Serves as primary liaison with sponsoring agencies and CROs, overseeing study start-up, TMF/eBinder management, document control, IRB submissions, and coordinating efforts among PIs, sponsors, and CROs.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Clinical Operations Manager
Northwestern University, Clinical Trials Unit
Chicago, Illinois
08.2024 - Current
- Manage the full regulatory lifecycle for Phase I-IV cardiovascular clinical trials (i.e., cardiovascular surgery, diagnostic, electrophysiology, interventional, and heart failure).
- Draft, submit, and manage initial IRB applications, protocol amendments, and annual continuing reviews, ensuring 100% compliance with institutional policies and federal regulations.
- Collaborate directly with multidisciplinary operating room teams—including surgeons, circulating nurses, and APPs—to seamlessly integrate and execute research protocols.
- Lead new cardiac specimen collection strategies, scaling research volume by over 100% through improved collection efficiencies.
- Direct a team of 5 CRCs, driving daily operations to consistently meet and exceed patient enrollment milestones and biospecimen collection targets.
Research Operations Manager
Northwestern University, Preventive Medicine
Chicago, Illinois
12.2022 - 08.2024
- Directed multi-site clinical operations and ensured regulatory compliance for 50+ staff, enhancing operational effectiveness across locations.
- Led research operations for controlled, randomized crossover nutrition trials, managing daily clinical workflows, intervention delivery, and data collection compliance to uphold high-quality data integrity.
- Collaborated with clinical sponsors to co-develop and finalize site-specific essential documents and regulatory files, ensuring readiness for study initiation.
Research Project Coordinator
Northwestern University, Preventive Medicine
Chicago, IL
09.2021 - 12.2022
- Managed 50+ staff across 3 clinical sites, optimizing resource allocation and ensuring strict protocol adherence.
- Directed operational workflows and vendor partnerships while overseeing budget allocation to meet tight deadlines across concurrent projects.
- Streamlined operations by coordinating participant visits with IDS, CRU, and core clinical units, ensuring protocol compliance and enhancing patient safety.
Senior Research Coordinator
Northwestern University, Preventive Medicine
Chicago, Illinois
01.2021 - 09.2021
- Led 30+ staff across two clinical sites, exceeding enrollment milestones with 2,500+ participants enrolled in Year 5 of grant.
- Launched new satellite site, ensuring regulatory compliance and operational readiness.
Research Study Assistant
Northwestern University, Preventive Medicine
Chicago, IL
08.2019 - 01.2021
- Recruited, screened, and consented participants 25+ patients per month according to protocol and IRB requirements.
- Collected vitals, anthropometrics, and biospecimens and maintained accurate source documentation.
- Maintained data integrity for 38,000+ EDC records and resolved queries promptly.
Research Assistant
University of Missouri
Columbia, MO
10.2018 - 05.2019
- Screened and consented participants, recorded responses, and analyzed data using MATLAB to support research findings.
- Investigated cognitive processes underlying episodic memory to contribute to understanding of memory mechanisms.
Education
Master of Science - Regulatory Compliance
Northwestern University
Evanston, IL06-2024
Bachelor of Science - Biology And Psychology
University of Missouri
Columbia, MOSkills
- Clinical Trial Management
- Phase I-IV Drug Trials
- EFS, Pivotal, Post-Market Device Trials
- Regulatory Specialist
- IRB Submissions
- Cardiovascular, Nutrition, and Genomics expertise
- Microsoft Office (Word, Excel, PowerPoint)
- EDC and eRegulatory platforms
Timeline
Clinical Operations Manager
Northwestern University, Clinical Trials Unit
08.2024 - Current
Research Operations Manager
Northwestern University, Preventive Medicine
12.2022 - 08.2024
Research Project Coordinator
Northwestern University, Preventive Medicine
09.2021 - 12.2022
Senior Research Coordinator
Northwestern University, Preventive Medicine
01.2021 - 09.2021
Research Study Assistant
Northwestern University, Preventive Medicine
08.2019 - 01.2021
Research Assistant
University of Missouri
10.2018 - 05.2019
Master of Science - Regulatory Compliance
Northwestern University
Bachelor of Science - Biology And Psychology
University of Missouri