Roxanne Navo
Denver,CO
Summary
Dynamic clinical research professional with a proven track record of exceptional quality as a site coordinator for industry-funded interventional trials. Skilled in managing multiple trials and ensuring compliance with ethical standards. Compassionate communicator dedicated to enhancing participant experiences while ensuring sponsor contracts are abided by.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Topography Health
Littleton, CO
02.2023 - Current
- Primary site coordinator for 7+ active clinical trials at a private practice. Shares responsibility for 18+ active clinical trials with one additional team member.
- Communicates effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Screens, schedules, and consents participants in a variety of clinical research programs and/or studies.
- Manages participant communications, protocol-specific activities, and unscheduled procedures from screening to study completion.
- Maintains accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, protocol deviations, informed consent.
- Collects, prepares, processes, ships, and maintains inventory of research specimens.
- Hosts interim monitoring visits, recruitment meetings, ad-hoc sponsor calls, and close-out visits. Upholds a harmonious relationship between the site and the sponsor.
Clinical Research Coordinator II
Sarah Cannon Research Institute
Englewood, CO
05.2022 - 02.2023
- Site's enrolling clinical research coordinator
- Perform venipuncture and log investigational product
- Communicate test results with participants
- Order labs and enter results in EMR
- Prepare for and participate in sponsor audits and/or regulatory inspections
- Complete all eCRFs, enter accurate and verifiable data into the EDC, resolve queries, and maintain source binders
- Complete adverse event CRFs and properly escalate to Sub-I or PI
- Communicate research enrollment metrics with Sub-I and central research team
Study Coordinator
University of Colorado
Aurora, CO
02.2021 - 05.2022
- Primary study coordinator for a state-wide NIH-sponsored registry
- Performs venipuncture and processes blood samples using a centrifuge
- Train junior coordinators
- Launched IRB-approved social media campaign to enhance patient recruitment
- Develop protocol for incidental findings for study participants with the department chair
- Work closely with the eye center’s communications program manager to create and run social media advertisements that adhere to the university’s guidelines
- Link services and charges to research grant for billing
- Send retinal images to physicians for review
- Participate in protocol review or study procedures planning
- Prepare for and participate in regulatory inspections
Education
B.S - Health and Exercise Science, Sports Medicine
Colorado State University
Fort Collins, CO05.2020
Skills
- Compassionate and effective in patient communication and care
- Strong ability to multitask
- Proven ability to work in a fast-paced environment
- Team collaboration
- Active Listening and Emotional Support
- Medical Equipment Operation
Clinical Research Skills
- Protocol Implementation & Management
- Informed Consent Process
- Electronic and paper source data
- documentation and management
- Adverse Event Identification & Reporting
- Subject Recruitment and Retention
- SOP Comprehension and Adherence
- Patient & Investigator Relationship Management
- Vital Signs and Lab Samples Collection
- Completes subject reimbursement and visit stipend for local and out-of-state participants
Certification
- FibroScan Certified Operator - 2024
- Phlebotomy certification - 2021
- Bone Fit Trained- National Osteoporosis Foundation - 2019
Timeline
Clinical Research Coordinator
Topography Health
02.2023 - Current
Clinical Research Coordinator II
Sarah Cannon Research Institute
05.2022 - 02.2023
Study Coordinator
University of Colorado
02.2021 - 05.2022
B.S - Health and Exercise Science, Sports Medicine
Colorado State University
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