Nicole (Colie) Sutter, Mph

Nicole (Colie) Sutter, Mph Email and Phone Number

Clinical Project Manager | Global Health | Phase II-IV | Cross-functional Team Leader | 5+ years Clinical Trials Management Experience | HIV | HTN | Advanced Lung Disease | Transplant | Regulatory Compliance @ San José State University
Nicole (Colie) Sutter, Mph's Location
San Francisco, California, United States, United States
Nicole (Colie) Sutter, Mph's Contact Details

Nicole (Colie) Sutter, Mph work email

Nicole (Colie) Sutter, Mph personal email

n/a
About Nicole (Colie) Sutter, Mph

Recognized Clinical Project Manager with 5+ years experience in Clinical Research, with therapeutic areas in: Advanced Lung Disease (Cystic Fibrosis, IPF, PH, COPD), Lung and Lung/Heart Transplant, COVID-19, HIV, HPV.5+ years clinical project management (4 global), from study start-up to close-out, including drug development processes and continual monitoring of regulatory milestones5+ years as primary author of regulatory document creation and submissions (CTAs, Protocols, IRBs, SOPs, eCRFs)4 years pre-award and grant applications for 5 Phase II-IV federally and commercially funded Global Clinical Trials3 years working closely with CRAs to monitor studies for audit readiness3 years SQL programming tracking clinical study progress3 years experience international program regulatory leadership (US and East Africa)2 years supervision and mentorship of junior research staff members (CRCs, Asst. CRCs, Lab)Currently serving as primary day-to-day project manager for 6 concurrent research projects in East Africa (80,000+ participants), in which I oversee all aspects of project lifecycle and ensure compliance with institutional and partner organization regulatory requirements.Let's Stay in touch!nmsutter@gmail.com

Nicole (Colie) Sutter, Mph's Current Company Details
San José State University

San José State University

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Clinical Project Manager | Global Health | Phase II-IV | Cross-functional Team Leader | 5+ years Clinical Trials Management Experience | HIV | HTN | Advanced Lung Disease | Transplant | Regulatory Compliance
Nicole (Colie) Sutter, Mph Work Experience Details
  • San José State University
    San José State University
  • Ucsf Health
    Clinical Project Manager
    Ucsf Health Mar 2021 - Present
    San Francisco, Ca, Us
    -Recognized for stand-out performance in a professional setting (2024 UCSF STAR SPOT Award for outstanding international project management and leadership).-Primary planner, organizer, and day-to-day project implementation manager for 6 concurrent clinical programs in East Africa (80,000+ participants), ensuring compliance with institutional strategic objectives. -Structured project tasks and ensured fidelity to scope of work for three simultaneous international working groups-Problem-solved and managed resources, setting the direction for the team assignments toward project goals, achieving 20% grade external audit improvements within one year-Prepared 3-5 project proposal submissions annually with 100% acceptance rate.-Developed SQL code for database analysis, identifying discrepancies with 25% faster resolution within one year. -Forecasted and monitored grant budgets, preparing monthly reports and suggestions for senior management, achieving 30% line-item savings.-Utilized consultative approach to identify and mitigate project risks, resolving issues with 30% faster turnaround time.-Synthesized trial regulations to create monitoring tools and training plans for study staff, reducing deviations by 35%.-Abstract author of 5+ submissions at internationally recognized conferences (CROI, IAS).-Ensured an updated Wix website and Facebook profile, promoting a current and relevant face to the project.
  • Ucsf Health
    Lead Clinical Research Coordinator
    Ucsf Health Jan 2020 - Mar 2021
    San Francisco, Ca, Us
    -Managed operations and research team for 13+ respiratory and cardiovascular investigational, observational, and pharmacovigilance healthcare implementation programs (COVID-19, Advanced Lung Disease, Heart/Lung Transplant). -Oversaw the hiring process for three assistant coordinators: developed job announcement, interview series, and offer package.-Supervised and trained junior staff, providing feedback on problem-solving strategies; including, risk management and escalation, audit preparedness, and issue resolution.-Reduced client attrition by 35% within one quarter through strategic quality assurance planning, utilization of project management tools, and developing systemic milestone tracking.-Originated on-going and upcoming project timelines and deliverables, leveraging department procedures and project management methodology (GANTT chart, SMART objectives).
  • Ucsf Health
    Assistant Clinical Research Coordinator
    Ucsf Health Jan 2019 - Jan 2020
    San Francisco, Ca, Us
    -Coordinated 6+ longitudinal and experimental research programs (Cystic Fibrosis, Advanced Lung Disease and Transplant), with recognized ability to improve project participation through interdisciplinary relationship building.-Developed functional and technical knowledge of project specialization through conducting literature reviews, attending pertinent conferences, and seeking out current or changed guidance.-Managed collaboration and interactions between clients, key stakeholders, investigative team, providers, and project partners.-Set agenda, presented analyses, resolved issues, and proposed recommendations for policy changes in weekly stakeholder working group meetings (virtual and in-person).
  • San Francisco Department Of Public Health
    Project Intern
    San Francisco Department Of Public Health Oct 2017 - Jun 2018
    San Francisco, Ca, Us

Nicole (Colie) Sutter, Mph Education Details

  • San José State University
    San José State University
    Public Health
  • San Francisco State University
    San Francisco State University
    Sociology
  • Antiguena Spanish Academy
    Antiguena Spanish Academy
    Spanish Language And Literature

Frequently Asked Questions about Nicole (Colie) Sutter, Mph

What company does Nicole (Colie) Sutter, Mph work for?

Nicole (Colie) Sutter, Mph works for San José State University

What is Nicole (Colie) Sutter, Mph's role at the current company?

Nicole (Colie) Sutter, Mph's current role is Clinical Project Manager | Global Health | Phase II-IV | Cross-functional Team Leader | 5+ years Clinical Trials Management Experience | HIV | HTN | Advanced Lung Disease | Transplant | Regulatory Compliance.

What is Nicole (Colie) Sutter, Mph's email address?

Nicole (Colie) Sutter, Mph's email address is ni****@****csf.edu

What schools did Nicole (Colie) Sutter, Mph attend?

Nicole (Colie) Sutter, Mph attended San José State University, San Francisco State University, Antiguena Spanish Academy.

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