Clinical Research Project Management

Ronda K. Ramsey, MSHS

******.******@*****.*** • 571-***-****

www.linkedin.com/in/rondaramsey• Centralia WA

Clinical Operations Leadership, Project and Program Management

Intro Video: https://youtu.be/hfWSdW3Ohgc

Results-driven executive leader and manager with proven years in research, specializing in project management and developing efficient research solutions from R&D to pre-study to close-out and after market with expertise in Clinical Research Program Oversight and Operations to Project Management using metrics, KPIs, and QMS principles.

Skilled in fostering collaboration among vendors, clients, sponsors, investigators, scientists and research teams, ensuring compliance with ALCOA+, GDP/GMP/GCP/GLP/GDPR, and CFR standards. Dedicated to process improvement strategic partnerships, and delivering exceptional outcomes in R&D and drug development.

Areas of Expertise

Program & Project Management

Clinical Research Management Oversight & Consulting

Regulatory Compliance & Submissions (FDA/Federal/International)

Professional Trainings

Data Management

Team Resourcing, Leadership & Development

Biorepository & Biobanking Research Lab/R&D Management

Technical Proficiency & Utilization

Collaboration & Stakeholder Management

Process Improvement & Quality Management

Data Analysis/Review/Reporting

Data Sourcing, Collection, EDC programing, Data Dictionary and data oversight.

Event Reporting & Safety Oversight

Phase I-IV, R&D, Device, After-Market, Start-Up, UE/UX, Investigator-initiated Trials

Academia, Hospital Systems, VA/Govt/NIH Grants and Healthcare Systems, Clinics, Biotech industries

Accomplishments

Won personal research grants, published author and successfully Trademarked my own innovative “Site Certification” process (2024).

Developed clinical research and biorepositories for 2 different biotech companies, clinical sites and the VA healthcare system. This included program resourcing, budgeting and finance, setting up SOPs/Manual of Operations, EDC (data dictionaries, oversight and programming), hiring, training and mentoring new teams. Program management and project management and implementation and development of project management tools, EDC, CTMS. Worked with laboratory personnel, LMS and AI data teams.

Management, running and oversight of nationwide and international studies – program and project protocols.

Successful Contracting, negotiations, collaborations with Sponsors, Pharmaceutical, Biotechs, Vendors, Investigators and Scientists.

Running and orchestration of nationwide in-person meetings, Investigator and Kick-Off Meetings. Large national conventions and meetings with PTC, NIH and CRO with over 50 sites and staff, Vendors, Sponsors to include presenting, running and management vendors, speakers and presenters.

Relationship management and management of escalations including internal and external customers.

Running successful meetings and documentation for: internal and external partners, vendors, Sponsors and teams

Successful implementation of versioning and documentation practices, eCTMS/CTMS set-up and management/reconciliations and audits.

Reconciliations and project/program audits completed with FDA, Sponsors, NIH/VA and Vendors to include internal audits and QA/QC. No adverse findings or issues reported in the programs and projects I have run and been responsible for.

Developed standards of measurements and operations for clinical research, including standards of collection and training for the NIH Pulmonary Cooperative Trials – 1st-year development. Developed and reviewed many protocols, ICF/DOA, Manual of Operations, Coding and Administration Manuals, IB Manuals, Training and Presentations, Safety and other manuals as needed, grant writing, reviews and technical/research writing and publishing.

Successfully defended RFPs and sales/won Sponsor contracted clinical research.

FDA submissions, regulatory and management of IND (drug and device studies) – Phase I-IV, After-market, Device.

Personal Bests:

Highest grant awarded: 150 million (Trial Runners, CRO)

Highest number of clinical trials/projects at one time: 23 (Viome)

Highest clinical site count for one study: 53 (Trial Runners - CRO)

Highest internal team count and management: 54 (Viome)

Indications: Optometry, Dermatology, Gastroenterology, Pulmonary, Endocrine, Neurology and CNS/TBI, Genomics, Oncology, Precision Oncology, Organoid Oncology, CAR-T Studies, Microbiome, Women’s Studies & Oncology, Qualitative and Quantitative, Device (Optometry, Dermatology, Degenerative Diseases), HIV/AIDs, Virology and Immunology, Rare disease and Orphan-Drug.

Developed KPI and metric reporting for the past 12 years for institutions, trials, projects, data reviews, risk-based monitoring and programs to help improve efficiencies and find and correct issues quickly and effectively saving money, time and alleviating protocol deviations and corrupt data. Performing CAPAs & CIPs and other mentoring and leadership training and re-training as needed.

Developed RACI and resourcing efficiencies using project management tools and team-building strategies to include hiring and job descriptions, training, SOP development, manuals and other staffing and resourcing tools to assure proper allocation of time, money and staffing for the past 9 years.

Successfully submitted and maintained approvals for IRB/FDA regulatory oversight of more than 55 total studies including R&D, After-market, and device studies.

Career Experience

Clinical Research Expertise Enterprises, Inc., Centralia WA (CRO/Contract/Remote) April 2024 – Present

Founder & CEO, Independent Clinical Research Contractor & Consultant

Consults on contracts, audits, reconciliations, site-startups, CRFs, regulatory, QC/QA reporting, KPI and metric reporting, protocol reviews and other clinical research consulting and technical writing.

Consulting to include Phase I – Phase IV novel therapies’ research in a start-up biotech company with formation of clinical research program start-up, helping to set up software and remote programs for EDC, data storage, data reviews/cleaning, storage and delivery to teams.

Consulting to include other Management Consulting Organizations, teaching and training on best practices, regulatory and FDA, IND applications.

Trademarked certification process for Site Certification and advanced readiness for clinical trials.

Data Management, analysis, troubleshooting, reporting, data programing, AI and other data functions and statistics.

Trial Runners, LLC (CRO), North Dakota, Centralia WA (Remote) September 2022 – March 2024

Director of Clinical Operations

Executive oversight of clinical operations, ensuring the improvement of processes, project management, and cross-functional team collaborations. Management of financial and budget contracts/oversight, regulatory submissions, and negotiations. Collaborated on pre-study start-ups, clinical studies, and digital data management to ensure compliance and reliable outcomes. Management of escalations, resourcing and timelines for programs and projects.

Development, training and mentoring teams, implementation of project management tools and technology, and development of generating KPI/metric reports with diverse internal and external teams.

Spearheaded the update of previous systems and project management to include: eCTMS/EDC/eCRF, manuals, protocols, and other study documents, enhancing study documentation and compliance.

Focused on Phase 1-2 studies with the highest safety standards, contributing to advancements in drug development, genetics, and device studies.

Used metrics and KPIs to initiate study and company-wide reporting efforts, driving efficiencies and updating SOPs/WINs and other templates, leading to improved operational performance.

Managed global and national studies across pharma, R&D, and device sectors (Phase II-IV, device studies) contributing to the successful execution of high-profile clinical trials.

SEngine Precision Medicine (Biotech/CRO/Sponsor), Seattle, WA February 2022 – September 2022

Sr. Manager of Clinical Operations

Oversight and management of the Clinical Operations of SEngine biotech laboratory, hiring, training, and collaboration with various teams and working groups. Developed and implemented project management systems, SOPs, and training programs for staff and site coordinators. Collaborated with investigators, physicians, and institutions, handled contracting, budgeting, financial projections, and patient services. Served as a troubleshooting advisor, ensuring compliance with GLP, GCP, and other regulatory standards.

Successfully created and integrated team and project SOPs, MOPs, and training programs using platforms like Monday.com, enhancing coordination and efficiency across clinical and research teams.

Managed IRB submissions and regulatory compliance at local, regional, national, and international levels, ensuring adherence to protocols and safety standards for ongoing trials and biorepository setups.

Spearheaded contracting coordination, legal negotiations, and financial projections, effectively managing budgets and timelines to support clinical operations and drug development projects.

Viome Research Institute (Biotech/CRO/Sponsor), Bothell, WA November 2020 – February 2022

Clinical Research Program Director

Developed a first-ever clinical research team for the microbiome biotech laboratory and pharma/supplement business. Supervised all aspects of research projects from development through publication. Operated programs, staff, and collaborations with national and international partners. Oversight of regulatory & IRB submissions, budgeting, study enhancement, program & project management, data management tracking and reconciliation. Negotiated contracts, led clinical trials, and managed teams to lead projects and trials. Set up biorepositories, with a focus on enhancing research infrastructure and team growth.

Successfully negotiated and secured four multimillion-dollar contracts with CROs, pharmaceutical companies, and biological research organizations, significantly enhancing research capabilities and funding.

Coordinated the physical relocation and setup of a laboratory from New Mexico to Bothell, WA, including the establishment of all infrastructure and clinical operations, which streamlined research processes and data collection.

Collaborated with East Coast AI team, and other Pharma teams worldwide to run clinical research, collected clean and accurate data, stored and transferred data to teams compliant to standards of different global regions.

Seattle Institute for Biomedical and Clinical Research, November 2018 – January 2021

VA Puget Sound Center of Excellence (WOC Status), (NIH Grant/Investigator-Initiated) Seattle, WA

National Study Lead Manager, Clinical Research Coordinator (National Protocol Leadership Group-NIH)

Working for the non-profit under grants from NIH and the VA Healthcare System, supervised multi-site national studies, including IRB submissions, safety event reporting, and lab management. Navigated biorepository operations, developed study protocols, and executed data collection and reporting. Facilitated pharmaceutical site trials, grant writing, and ensuring adherence to NIH and government standards. Played a pivotal role in the start-up and oversight of precision oncology trials, collaborated with nonprofits, and directed complex studies such as those for metastatic prostate cancer and advanced urothelial cancer.

Established and administered the Precision Oncology Network (NPOP) through NIH, including the formation of working groups and collaboration meetings, which defined processes for national precision oncology trials and significantly advanced research infrastructure.

Integrated and monitored multiple high-impact national and multi-center clinical studies, including complex trials for metastatic castration-resistant prostate cancer, such as the Phase II and Phase III studies (ClinicalTrials.gov Identifiers: NCT04038502, NCT04104893, NCT02952534), demonstrating expertise in managing large-scale research projects and cross-site coordination.

Additional Experience

Research Director/Administration, Aesthetic & General Dermatology of Seattle & Bellevue, WA

Clinical Research Coordinator (National Protocol Leadership Group, Lead Study Coordinator), Seattle Institute for Biomechanical and Clinical Research, VA Puget Sound Health Care System (HSR&D, WOC Status), Seattle WA

Clinical Research Data Manager, University of Washington, Pulmonary & Critical Care Division, Seattle, WA – Data Oversight/Analysis/Reporting/Reconciliation/Cleaning.

Further experience in clinical employment, services, residences & internships as a National Membership Director & Research Distribution Coordinator for American Association of Naturopathic Physicians, Mental Health & Behavioral Health Technician for Hopewell House for Independent Living, and as a Radiology Technician for Norfolk General Hospital & Trauma Center & Children’s Hospital of the King’s Daughters. Additionally, as a Dental Office Manager for two different dental clinics and Treatment Planner, and Medical OB/GYN transcriptionist and reporting for Mountain Area HealthCare (MAHEC). Office Manager and Medical Transcriptionist for Key West Mental Health Services Clinic.

Additional Research: AIDS/HIV Immunotherapy and Pregnancy Research, Orphan Drug Disease Therapies (George Washington University Medical School), Sensory Perception, Neurology and DOD/Toyota UE/UX, Rainforest Ecology and Marine Ecology Research (George Mason University), Qualitative and Quantitative, Neuropsychology Research (Old Dominion University), Animal Physiology & Endocrinology Research (University of North Carolina, Asheville) –

Indications: Pulmonology, Immunology, Endocrinology, Ecology, UE/UX, Oncology, Genomics, Microbiome, Repository (Data and Sample), Ophthalmology, Dermatology, Psychology & Psychiatry, Physiology.

Institutional Experience: Hospital systems, Academia, Private clinics, CRO, Contracting/consulting, Insurance, NIH and VA (Federal Funding and Grants).

Education

Master of Science in Health Science (MSHS), Clinical Research Administration

The George Washington University, Medicine & Health Science, Washington, DC, May 2015

Bachelor of Science (BS) in Cognitive Science, Psychology

George Mason University, Fairfax, VA, January 2012

Studies in Animal Physiology, Chemistry, Zoology

University of North Carolina, Asheville, NC, 1997

Studies in Pre-Med, Brain Physiology, Qualitative/quantitative analysis, Advanced Biology

Old Dominion University, Norfolk, VA, 1995

Associate of Science in Science (ASS), Biomedical Science – Psychology/Radiology

Tidewater Collage, VA, 1994

Graduate, Science track: AP Biology, Physics, Chemistry, Computer Science, Horticulture, Ecology, Forestry

Coeur D’ Alene High School, Coeur d’ Alene, ID, June 1987

Certifications

Project Management Coursework

CFR Coursework (Regulatory Law - Master’s level), 4 years of statistics classwork (SPSS/SPS/MatLab/Minitab)

CITI Certifications (Biohazard, OSHA Blood-borne Pathogens, DURC, GCP/GLP. ICH, Human Subjects Protection, Conflicts of Interest, Biomedical Research, Biosafety, IPS, USDA, Animal Biosafety, Biosafety Committee Member Training, Personal Protective Equipment, Nanotechnology, Biosafety Officer Training, Shipping and Transport of Regulated Biological Materials, Human Gene Transfer, NIH Recombinant DNA Guidelines)

NIH Certifications (Protecting Human Research Participants, Laboratory Safety)

HIPAA Certification & Maintenance

Stericycle Certifications (Blood Borne Pathogens Training, Biohazardous Waste Training)

Mayo Clinic Laboratories Certifications (Category A & B Biohazard Shipping, Transporting Dangerous Goods, ASCLS P.A.C.E.)

HeartCode Certifications (Advanced CPR, BLS CPR)

Physicians Insurance: HIPAA

Castor EDC, Metadata, REDCap and other EDC, eCTMS, eDTA Certifications

Regulatory Submissions (VA, Government, Academia, Hospital Systems, Sponsored Research, Clinical Sites)

VA Federal Security Clearance & Training (Privacy & HIPAA, Active Threat, Elevated Privileges for System Access (WBT), Information Security & Privacy Role-Based Training for System Administrators (WBT), COVID-19 Clinical Staff, VA Privacy & Information Security Awareness & Rules of Behavior)

Professional Organizations & Associations Clinical Research Related

The Association of Clinical Research Professionals (ACRP)

National & Pacific NW Chapter

The Society of Clinical Research Associates (SoCRA)

National & Washington Chapter

Model Agreements & Guidelines International (MAGI)

American Association for the Advancement of Science (AAAS)

American Lung Association (ALA)

The George Washington University Alumni Association (Washington Chapter)

Other Organizations: Environment Washington, Amnesty International, Conifer Society, Sea Shepherd Conservation Society, US Bonsai, NW Bonsai Association, PNW Kayak.

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