Anna-Marie Locher

Experience

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  Physicians' Research Option's LC

  Sept 2004 - Apr 2012

  Site Manager, CCRC

  Physicians’ Research Options, LCManagement and Coordination of SMO-Staffing 7 MDs/PI’s, 3 NPs/Sub-I’s and associated MAs specializing in Woman’s Health. Duties include: the day-to-day operation of Phase II-IV Protocols. Providing detailed Management and Quality Assurance, Site and Regulatory Start-up, IRB Submissions, GCPs, Contracts and Budgets, Protocol and maintenance of Staff Training. Always working to develop outstanding working relationships, trust and integrity with Sponsors, Vendors, IRBs, FDA and most importantly, Patients. Keeping strict adherence to GCPs/SOPs in Consenting, HIPPA, AE/SAE, Query Resolution, Data Collection and EDC entry. Developing Excel spread sheets to assist in providing excellent adherence to Inclusion/Exclusion criteria, Recruitment, Screening and Coordinating of all study specific criteria, visit windows and procedures; Pre-Study through Close-out. Staying current in the ever-changing Regulations and Guidelines, to all Governing Bodies; Federal and Local to ensure patient safety and high-quality data Show less

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  Colorado Orthopedic Consultants

  Mar 2014 - Sept 2016

  Director of Research

  Colorado Orthopedic ConsultantsManagement and Coordination of 5 PI/Sub-I group, each with their own MA, 2 satellite sites specializing in Orthopedic Medicine. Duties included: the day-to-day operation of Phase II-IV Protocols, Site and Regulatory Start-up, Budgets, Hiring/Payroll. Coordination and Protocol Staff training. development and revision of documents and study support material. Develop training manuals and training of new staff/protocols. QA Monitoring of documentation and case reports, Track the progress of projects. Ensure performance expectations are met within all departments. Keeping strict adherence to GCPs/SOPs in Consenting, HIPPA, AE/SAE, Query Resolution, Collection, EDC entry and prompt query resolution to meet Sponsor deadlines all while maintaining the highest quality, trust and integrity with patients, Sponsors, Vendors, IRBs, and FDA. Show less

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  Mountain View Clinical Research, INC.

  Sept 2016 - Aug 2018

  CCRC., Mentor

  Mountain View Clinical Research, Inc., Coordination of multiple phase II-llI studies. Duties from Study start up – Closeout. Providing Detailed Submissions and Maintenance of Regulatory documents and Safety reports. Pursuing continuous Training and Experience, demonstrating Proficiency in Clinical and non-clinical delegated duties. Follows strict adherence to GCP’s / SOP’s. Upholding the safety of study subjects and quality of study data by assuring protocol compliance and timely Data collection. Establishing excellent communication and effective working relationships with Sponsors, Vendors, Staff, and most importantly patients trust. Exceeding exceptional patient compliance and retention. Show less

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  University of Colorado Anschutz Medical Campus

  Feb 2020 - now

  Sr. Auditor

  Data & Safety Monitoring Committee (DSMC)

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  University of Colorado Cancer Center

  Oct 2022 - now

  • DSMC Manager

    Oct 2022 - now

  • DSMC Manager

    Oct 2022 - now

  • DSMC Manager

    Oct 2022 - now