Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

FRANCES MICHELLE SANDFORD

Richmond,TX

Summary

Accomplished 20 year experienced certified clinical research professional with a proven track record at Next Level Medical achieving 90% enrollment targets. Expert in clinical study management, budget oversight, and fostering team leadership. Excelled in optimizing study logistics and ensuring regulatory compliance, significantly enhancing operational efficiency and clinical outcomes.

Overview

17
17
years of professional experience

Work History

Director of Clinical Research

Next Level Medical LLC
Houston, TX
07.2020 - Current
  • Managed all components of clinical studies, including Phase I trials, from start-up to close-out
  • Provided proactive financial oversight, ensuring adherence to budgets and delivering cost-efficient results
  • Oversaw vendor and CRO processes, ensuring deliverables met study protocols and timelines
  • Defined study logistics developed comprehensive clinical study plans, and optimized project efficiencies
  • Directed site operations, including evaluations, monitoring visits, and compliance reviews
  • Led a high-performing team, fostering a collaborative and communicative work environment

Research Manager

Liver Associates of Texas
Houston, TX
06.2019 - 07.2020
  • Actively managed clinical study budgets, recovering $100,000 in previously uncollected revenues
  • Contributed to SOP development and special projects to improve operational efficiency and study outcomes
  • Provided oversight for site operations and ensured compliance with regulatory requirements
  • Collaborated cross-functionally to resolve challenges and streamline clinical trial processes

Partner

Phoenix Clinical Research, Inc.
Sugar Land, TX
10.2009 - 06.2019
  • Directed operations across four clinics, achieving 90% enrollment targets and subject completion rates
  • Provided oversight for site logistics, regulatory compliance, and documentation management
  • Enhanced patient recruitment and retention strategies, ensuring consistent success across studies

Clinical Research Site Manager

Impulse Clinical Research Group, Inc.
Houston, TX
01.2008 - 01.2009
  • Directed site-level clinical trial activities, ensuring adherence to GCP and study protocols
  • Developed tools and processes to improve trial efficiency and monitoring

Education

Bachelor of Science - Nursing

Pines City Colleges
Baguio City, Philippines

Skills

  • Clinical Study Management (Phase II-IV)
  • Budget Oversight & Financial Management
  • Vendor & CRO relation
  • Study Logistics & Planning
  • SOP Development & Process Optimization
  • Regulatory Compliance (ICH-GCP)
  • Data Integrity
  • Team Leadership & Training
  • Good Clinical Practices (GCP)
  • Budget Management & Financial Oversight
  • Contract Negotiation & Management
  • Clinical Quality Improvement & Reporting
  • Regulatory Compliance & Protocol Management

Accomplishments

  • Generated $3M in revenue through high-profile COVID-19 studies, significantly enhancing the research portfolio.
  • Collaborated with prestigious sponsors, including Pfizer, Regeneron, Merck, and Gilead, to deliver successful trials.
  • Established and Scaled Research Operations: Successfully launched a clinical research department from the ground up, including recruiting, hiring, and training a high-performing team of clinical research professionals. Developed operational workflows, implemented best practices, and fostered a collaborative culture, ensuring the department's long-term success and scalability.

Timeline

Director of Clinical Research

Next Level Medical LLC
07.2020 - Current

Research Manager

Liver Associates of Texas
06.2019 - 07.2020

Partner

Phoenix Clinical Research, Inc.
10.2009 - 06.2019

Clinical Research Site Manager

Impulse Clinical Research Group, Inc.
01.2008 - 01.2009

Bachelor of Science - Nursing

Pines City Colleges
FRANCES MICHELLE SANDFORD