Anna-Marie Locher
CCRC/Clinical Operations
Littleton,CO
Summary
Results-driven Clinical Research Coordinator with a strong track record in Phase I-IV trial management and patient safety oversight. Led successful audit operations and quality improvements across multiple therapeutic areas, driving regulatory compliance and participant advocacy. Developed impactful SOPs and training programs, enhancing research staff capabilities and operational excellence.
Overview
1
1
Certification
20
20
years of professional experience
Work History
DSMC Manager / Senior Auditor
University of Colorado Cancer Center
01.2022 - 01.2024
- Oversaw DSMC operations, ensuring protocol compliance, enhancing patient safety oversight, and analyzing AE/SAE trends for the CU Cancer Center research portfolio.
- Developed SOPs, guidance documents, and work instructions; led quarterly safety reviews, presenting audit findings to research leadership to inform decision-making.
- Developed strategic initiatives to improve departmental workflow efficiency.
- Managed team operations to ensure effective patient care delivery.
- Coordinated staff training programs to enhance service quality and compliance.
DSMC Senior Auditor
University of Colorado Cancer Center
01.2020 - 01.2022
- Led audit planning and execution for financial operations at a cancer research institution.
- Conducted audits of Phase I-V trials at CU Cancer Center, Children’s Hospital Colorado, Veterans Affairs, and City of Hope to ensure compliance with regulatory standards.
- Evaluated compliance with federal regulations and institutional policies in audits.
- Evaluated consent, eligibility, source documentation, AE/SAE reporting, and regulatory compliance; facilitated CAPA development and provided staff training.
- Collaborated with research teams to assess grant funding and expenditure processes.
Director of Research
Colorado Orthopedic Consultants
01.2014 - 01.2016
- Directed research operations for five PIs and three satellite sites, managing Phase II-IV protocol lifecycle from start-up through closeout to maintain compliance and complete study execution.
- Managed research projects to support orthopedic clinical practices and patient outcomes.
- Collaborated with medical staff to identify research needs and priorities.
- Developed protocols and methodologies for data collection in orthopaedic studies.
CCRC / Satellite Site Manager
Physicians' Research Options, LC
01.2004 - 01.2012
- Oversaw SMO staffing for seven MDs/PIs and three NPs in women’s health Phase II-IV studies, ensuring GCP/SOP compliance and fostering strong sponsor relationships.
- Managed daily site operations to ensure compliance with regulatory standards.
- Coordinated staff schedules and assignments to optimize workflow efficiency.
- Led team meetings to discuss project updates and address site challenges.
Education
BS - Technical Management (Health Services)
DeVry University
Westminster, CO01-2019
Skills
- Regulatory compliance
- Stakeholder Engagement
- CAPA management
- Safety reporting
- Trial management
- EDC Entry & Query Resolution
- Documentation management
- Operations & Safety Oversight
- Stakeholder collaboration
- Stakeholder Engagement
- Training and mentorship
- Employee development
- Coaching
- Therapeutic Area Expertise
- Stakeholder Engagement
Personal Information
Title: Certified Clinical Research Coordinator (CCRC)
Certification
CCRC 2008Present, ICH/GCP E6-R3 Refresher May 2025, ISO 14155 Medical Devices Training
Affiliations
- ACRP Front Range Chapter, Board Member (2008Present)
- SOCRA (2022Present) NSLS (2019Present)
Recognitions
Pfizer Excellence Award Outstanding recruitment, retention, and ethics Syneos Health Site Award Commitment to clinical development
Timeline
DSMC Manager / Senior Auditor
University of Colorado Cancer Center
01.2022 - 01.2024
DSMC Senior Auditor
University of Colorado Cancer Center
01.2020 - 01.2022
Director of Research
Colorado Orthopedic Consultants
01.2014 - 01.2016
CCRC / Satellite Site Manager
Physicians' Research Options, LC
01.2004 - 01.2012
BS - Technical Management (Health Services)
DeVry University