Rachel Fadden
Tolleson
Summary
Dynamic Site Director skilled in overseeing clinical trials from initiation to completion, ensuring compliance with regulatory standards. Expertise in resource planning, team training, and process improvement, contributing to enhanced trial outcomes and operational excellence. Holds a Bachelor's degree in Science, fostering a compliant and productive research environment.
Overview
11
11
years of professional experience
Work History
Site Director
Trialmed
Phoenix
03.2022 - Current
- Ensures execution of site protocols and provides daily direction to the site's staff
- Liaised between investigator and research team, coordinating clinical research activities in compliance with SOPs, ICH/GCP, and FDA guidelines.
- Supported global business objectives by planning and coordinating resources and facilities to ensure quality management and target delivery.
- Oversee site operations to ensure compliance with regulatory standards.
- Collaborated with cross-functional teams to streamline site processes and workflows.
- Manage staff schedules and coordinated training programs for new employees.
Lead Clinical Research Coordinator
Trialmed
Phoenix
04.2021 - 03.2022
- Coordinated clinical trials from initiation to completion following regulatory guidelines.
- Coordinated site operations, focusing on recruitment, enrollment, and retention of study participants to achieve trial objectives.
- Trained and guided junior team members, enhancing their skills and knowledge in clinical trial processes.
- Completed all source documentation to capture data specified by the study protocol.
Clinical Research Coordinator II
Trialmed
Phoenix
12.2019 - 04.2021
- Coordinated multiple clinical trials involving patients and healthy volunteers, ensuring adherence to study protocols.
- Managed documentation processes to accurately capture data outlined in study protocols, facilitating regulatory compliance.
- Collaborated with research site team and interdepartmental staff to streamline participant recruitment and retention efforts.
- Engaged in the entire site operations process, which includes recruitment, enrollment, and retention of study participants.
- Enhanced participant retention in clinical trials through effective communication and engagement techniques.
Site Manager
Trialmed
Phoenix
04.2018 - 12.2019
- Oversaw day-to-day activities, performance, and supervision of research site, ensuring compliance with protocols and effective staff direction.
- Ensured execution of site protocols and provided daily direction to the site's staff.
- Acted as liaison between the investigator and research team, coordinating clinical research activities according to the organization's SOPs, ICH/GCP, and FDA guidelines.
- Coordinated site activities to ensure compliance with regulatory standards.
- Oversaw team performance and facilitated training for new staff members.
- Supported the globally aligned business objectives, growth, delivery of targets, quality management as well as the appropriate planning and coordinating of resources and facilities.
Clinical Research Coordinator I
Trialmed
Phoenix
04.2017 - 04.2018
- Coordinated recruitment efforts for clinical trials and ensured participant compliance.
- Managed trial documentation and maintained regulatory compliance throughout study phases.
- Coordinated with research site team and interdepartmental staff to foster positive patient interactions throughout study planning, from initiation to closeout.
- Facilitated communication between investigators, sponsors, and study participants effectively.
- Conducted ongoing clinical trial involving patients or healthy volunteers.
Research Assistant
Trialmed
Phoenix
10.2016 - 04.2017
- Collaborated with team members to design and implement research protocols.
- Conducted literature reviews to support clinical research projects at Trialmed.
- Analyzed data using statistical software to ensure accurate findings.
- Coordinated technical procedures, gathered and verified study-specific and patient data, and collected source documentation for medical history.
Recruitment Manager
Arizona Research Center
Phoenix
07.2015 - 10.2016
- Created recruitment plans for current and upcoming trials, aligning strategies with project objectives.
- Developed recruitment strategies to attract top talent for Arizona Research Center.
- Collaborated with department heads to define job requirements and candidate profiles.
- Managed the full recruitment lifecycle, from sourcing to screening of patients.
- Conducted patient recruitment calls for ongoing and upcoming trials, facilitating participant engagement.
- Ensured thorough understanding of clinical trial protocols and compliance with GCP standards.
Administrative Assistant
Premier Research
Phoenix
03.2015 - 07.2015
- Managed daily office operations and maintained administrative workflows.
- Coordinated meetings and prepared materials for team discussions.
- Managed supplies inventory by checking stock levels, anticipating needs, placing and expediting orders, and verifying receipt of supplies to support operational efficiency.
- Prepared project documents, including payment invoices for physicians and patient stipends, facilitating accurate financial processes.
- Assisted in project scheduling and tracked progress of deliverables.
- Coordinated patient schedules, including surgery scheduling for ongoing surgical trials, ensuring timely appointments.
Education
Bachelors of Science (B.S.) - Unity, ME, US
Unity Environmental University
Unity, ME, US06-2025
Skills
- Clinical trial coordination
- Regulatory compliance
- Site operations management
- Clinical trial strategy
- Operational leadership
- Resource allocation
- Recruitment strategies
- Data management
- Patient engagement
THERAPEUTIC EXPERIENCE
- Vaccine Immunology: RSV Vaccine (5 yrs), COVID-19 Vaccine (5 yrs), Other vaccinations (5 yrs)
- Men's Health: Hypogonadism (5 yrs)
- Cardiovascular: Hyperlipidemia (4 yrs), CV Outcome (8 yrs), Hypercholesterolemia (1 yrs), Statin Intolerance (4 yrs)
- Endocrinology: Type 2 Diabetes (9 yrs), Obesity (3 yrs)
- Respiratory: COPD (1 yrs), Asthma (1 yrs)
- Gastroenterology: IBS-D (2 yrs), Crohn's Disease (1 yrs), Colorectal Cancer Screening (2 yrs) Eosinophilic Esophagitis (2 yrs)
- Musculoskeletal: Osteoarthritis (3 yrs)
- Pain: Low Back Pain (1 yrs), Diabetic Peripheral Neuropathy (1 yrs)
REGULATORY EXPERIENCE AND EXPERTISE
- Experience with central IRB and IBC submissions, continuing reviews, reportable events & closures
- Significant experience in regulatory affairs in US
- Experience with regulatory authorities and associated business teams
- Experience with routine regulatory authority audits and inspections
- Areas of Regulatory Expertise: vaccine immunology, cardiovascular, men's health, healthy volunteers, endocrinology
Timeline
Site Director
Trialmed
03.2022 - Current
Lead Clinical Research Coordinator
Trialmed
04.2021 - 03.2022
Clinical Research Coordinator II
Trialmed
12.2019 - 04.2021
Site Manager
Trialmed
04.2018 - 12.2019
Clinical Research Coordinator I
Trialmed
04.2017 - 04.2018
Research Assistant
Trialmed
10.2016 - 04.2017
Recruitment Manager
Arizona Research Center
07.2015 - 10.2016
Administrative Assistant
Premier Research
03.2015 - 07.2015
Bachelors of Science (B.S.) - Unity, ME, US
Unity Environmental University