Arynne Wilburn
Brandywine
Summary
Dynamic Senior Research Program Coordinator at Johns Hopkins University with expertise in clinical trial management and data analysis. Proven track record in leading diverse research teams and enhancing operational efficiency. Skilled in grant writing and effective communication, driving successful project outcomes while ensuring patient safety and data integrity.
Overview
7
7
years of professional experience
Work History
Senior Research Program Coordinator
Johns Hopkins University
10.2023 - Current
- Company Overview: School of Medicine
- Provide for the daily operation, study visits, sample collection, data entry, and query resolution for Multiple clinical research studies and trials.
- Support numerous, diverse medical chart data extraction studies and educate others in the collection organization, and analysis of clinical data for publication and grant and proposal preparation.
- Collaborate with research team on scientific implementation, daily operation, and data management of interventional clinical trials.
- Conduct study subject visits.
- Provide for the acquisition and processing of clinical samples from study subjects.
- Develop tools for study implementation including web-based case report forms, standardized order sets, investigator-initiated protocols and consent forms.
- Under the direction of physician principal investigators, patient study eligibility, obtain informed consent, and initiate patient randomization and enrollment.
- Act as a liaison for various studies with sponsors, study monitors, patients and their primary care providers.
- Assist in the development of standard operating procedures and regulatory policy for the center.
- Provide backup support for the program regarding patient scheduling.
- Occasional on-call required for night and weekend program activities.
- Coordinated Monitoring and SIV meetings
- Grant Writing
- Manage Research Coordinators of projects
- Provided technical assistance to research teams in developing new initiatives or refining existing ones.
LAB INSTRUCTOR,
GEORGE WASHINGTON UNIVERSITY, DEPARTMENT OF BIOLOG
Washington DC
10.2024 - 12.2024
- Facilitated group discussions among students about topics related to laboratory experiments.
- Ensured that all safety guidelines were followed by students when working in the lab environment.
- Established laboratory policies regarding the use of chemicals, instruments, and equipment.
- Provided guidance and support to students during laboratory sessions.
- Developed innovative teaching methods using technology-based learning tools such as online simulations.
- Prepared instructional materials such as syllabi, homework assignments, and handouts.
- Conducted experiments and demonstrations for students to gain a better understanding of concepts.
Clinical Research Coordinator II
Atlanta Medical Research Center
08.2023 - 10.2023
- Responsible for coordinating all aspect of Clinical trials with limited oversite with adherence to ICH, GCP, protocol, and site guidelines, regulations, and policies.
- Responsible for the delegation of tasks to Research Assistants ensuring the accurate completion and maintenance of study components and duties.
- Supervisory duties include assessing the daily performance and productivity of designated research assistants and assisting in CTM planning and training.
- Duties also include the creation of source documents, participating in IMs and SIVs, enrolling participants into studies, coordinating study visits and adhering to protocol, participate in oversight of Vendors, Accounting, Regulatory, Client Satisfaction, Recruitment, Quality and Trial Outcomes.
- Responsibility also includes coordinating all aspects of patient involvement from study initiation until study completion and ensuring all documentation is quality assured and data is accurately captured.
Clinical Research Coordinator I
Emory University
01.2021 - 05.2023
- Under the RADx Project: Directed administrative activities (university associated) with the conduct of centralized and decentralized clinical trials.
- Maintains data pertaining to research projects, completes source documents/case report forms, and performs data entry.
- Contributes to patient recruitment.
- Attends study meetings.
- Organized collection of study specimens including phlebotomy, processing, and preparation for shipping.
- Coordinated services, schedules procedures, creates and maintains case packages, and monitors charges.
- Supports with quality assurance and tracks regulatory submissions.
- Performs related approved responsibilities as required.
Associate Clinical Research Operations Program Manager
Care Access
10.2022 - 04.2023
- Assists in directing and coordinating the Operations of the Decentralized Clinical Trials team.
- Worked with a multidisciplinary team.
- Supports the Operations Program Manager and Project Manager to work with POD Managers on assignments.
- Work with the organization to solve potential struggles and challenges under the direction of the Operation Program Manager.
- Assist in developing Key Performance Index (KPI) measurement tools to ensure the team delivers the highest quality results.
- Support the research team and ensure we are solid advocates for the patients served.
- Some of my duties include monitoring Project Management execution for the team, assisting POD managers with Invoicing for contractors, amplifying team culture with a focus on collaboration and teamwork to ensure patient safety and data integrity, advocating for the POD Management team, assisting with interprofessional collaboration to the POD Management team to assist with assignments/requests and reassess for additional support at sites, and assisting with the appropriate workload for individual POD Managers and support where needed.
- Managed Data and presented findings
- Maintained accurate records of all program-related activities including expenses.
Lead Travel Research Coordinator
Care Access
06.2022 - 10.2022
- Responsible for the overall site conduct under the direction of the Pod Manager / Site Manager for all Decentralized Trials.
- Assisted in Protocol Coordination.
- Ensured delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and SOPs in all aspects of conducting clinical trials.
- Was able to function and still partake in all levels of a Clinical Research Coordinator.
- I made sure the research projects were well-organized and that they ran smoothly.
- I communicated with various departments in the organization to ensure everyone was on the same page.
- Assisted with IRB submissions and Audit preparations and coordinated all lab activities, including ordering lab equipment, shipment of labs, and obtaining lab results.
Travel Research Coordinator
Care Access
05.2022 - 06.2022
- A floating support system that helps in much research decentralized clinical trial projects throughout the United States to create valid and concise results needed for the project/task.
- Creates the mobile units and the filing systems for the team to complete tests.
- Quality controls all data and documents.
- Phlebotomy trained and handled specimen collection.
- Managed participant participation and consenting patients.
- Handled data management in guidance with the QA (quality assurance) team and worked with LabCorp and Q2 solutions to track and interpret lab results.
Graduate Research Assistant
Emory University
12.2021 - 05.2022
- Worked with the MIDST Project by performing data entry work with the systems excel, adobe, and Redcap.
- Research Tuberculosis and the epidemiologic methods conducted while working with Tuberculosis.
- Attend meetings for multiple projects in the department of Epidemiology and Global Health.
Lab Assistant
Piedmont Atlanta Hospital
03.2021 - 05.2022
- Performs sample processing and exempt screening and monitors tests in accordance with CMS (CLIA '88), OSHA and the Georgia department of community.
- Phlebotomy trained.
- Performs venipunctures and obtains/prepares blood specimens.
- Supports technical staff in non-clinical and clinical tasks.
- Assist in research laboratory work for centralized and decentralized clinical trials.
Research Assistant
National Institute of Environmental Health Sciences
06.2020 - 12.2020
- Working with the DLH Corp, I co-managed study coordination of multiple projects, managed multiple tasks simultaneously and delegated administrative responsibilities.
- Tasks included data entry activities in accordance with NIH (National Institutes of Health) and FDA (Food and Drug Admin) regulations such as receiving, reviewing, and entering data and source documents into clinical databases, participated in study activities including patient recruitment, screening, and enrollment via the various on and off-site procedures, patient chart and medical records review, and quality control of collected patient and physician forms.
- Assisted with development and maintenance of study operation procedures, manuals and other technical guides, preservation of tracking sheets, aided with study related regulatory documents, developed study timelines, task lists, and tracking tools, organized central study and contract files, led tasks related to participant samples transport and tracing, and completion of regulatory documents including Materials and Data Sharing Agreements.
Research Assistant
U.S. Naval Academy
07.2020 - 08.2020
- Working with the Henry M Jackson Foundation, I aided the Principal Investigator and Research Coordinators with the baselining of midshipmen per the NCAA DoD Grand Alliance: Concussion Assessment, Research and Education (CARE) study during the summer.
- Conducted collection of baseline data in support of the CARE initiative, as well as the overall support of the warfighter.
- Provided critical support for USNA midshipmen, clinical care providers, and groundbreaking research in the field of traumatic brain injury (TBI).
- Analyzed data collection in adherence to the Occupational Safety and Health Administration (OSHA), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) baseline assessment measures.
- Conducted administrative logistics including consenting, data collection, participant oversight, and scheduling.
- Facilitated the administration of concussion baseline assessments.
- Maintained subject files and documents all correspondence pertinent to the research study.
- Lastly, they always promoted safety and confidentiality of research participants.
Nutrition Research Associate
Mathematica Policy Research
02.2020 - 03.2020
- Under the supervision of the USDA and FDA, my responsibilities entailed reviewing completed menu surveys to identify missing data, following up with School Nutrition Managers to retrieve this data, and finalizing menu survey data in an online system.
- I also assessed the productivity and accuracy of the menu surveys and worked with project staff to resolve any issues that may have arisen during the process.
Lab Assistant
Grace Medical Center and Life Bridge Health
02.2018 - 02.2020
- Medical Secretary for the Chemistry, Hematology, Microbiology, Immunology, and Pathology Departments.
- Worked with billing and conducting day to day lab work.
- Organized all files regarding pathology work and prepared the Pathology specimen on the slides.
- Recorded the daily statistics for all departments.
Education
MASTER OF PUBLIC HEALTH - Epidemiology
GEORGE WASHINGTON UNIVERSITY
Washington, DC05.2025
Bachelor of Science - Health Science
COPPIN STATE UNIVERSITY
Baltimore, MD05.2020
Skills
- Survey and ICD data analysis
- Microsoft Office proficiency
- Customer service excellence
- Specimen transportation
- Medical scribing
- Billing management
- Statistical analysis
- Venipuncture techniques
- Phlebotomy skills
- Clinical trial databases
- Veeva Vault expertise
- EPIC systems knowledge
- Health administration practices
- Decentralized clinical trials management
- Centralized clinical trials oversight
- Phase I to III trial experience
- Project management
- Effective communication
- Team collaboration
- Collaborative research
- Qualitative research
- Trend identification
- Clinical trial management
- Data analysis
- Policy analysis
- Leadership and change management
- Root-cause analysis
- Multitasking capacity
- Customer service management
- Employee supervision
- Report preparation
- Clinical trial expertise
- Customer segmentation
- Redcap
- EndNote
- Trial Design
- Critical thinking
- Project planning
- Expertise in grant writing
- Manuscript formatting
References
- Dr. Watties-Daniels, Denyce, Associate Professor and Interim Co-Chairperson, Baccalaureate Nursing Program, 410-951-3974
- Mrs. Russell, Vanessa, Professor of Speech and Communication at Coppin State University
- Ms. Reat, Amanda, Epidemiologist and Researcher, 512-569-5513
- Rochelle Whittington, Senior Manager of Clinical Trials at Care Access, rwhittington771@gmail.com
- Anthony Greeson, Senior Manager of Clinical Trials at Care Access, 256-557-8444
- Denise Daniel, District Manager of Operations, 508-617-7960
- Stephanie Bottomley, Program Manager, 513-293-2060
Timeline
LAB INSTRUCTOR,
GEORGE WASHINGTON UNIVERSITY, DEPARTMENT OF BIOLOG
10.2024 - 12.2024
Senior Research Program Coordinator
Johns Hopkins University
10.2023 - Current
Clinical Research Coordinator II
Atlanta Medical Research Center
08.2023 - 10.2023
Associate Clinical Research Operations Program Manager
Care Access
10.2022 - 04.2023
Lead Travel Research Coordinator
Care Access
06.2022 - 10.2022
Travel Research Coordinator
Care Access
05.2022 - 06.2022
Graduate Research Assistant
Emory University
12.2021 - 05.2022
Lab Assistant
Piedmont Atlanta Hospital
03.2021 - 05.2022
Clinical Research Coordinator I
Emory University
01.2021 - 05.2023
Research Assistant
U.S. Naval Academy
07.2020 - 08.2020
Research Assistant
National Institute of Environmental Health Sciences
06.2020 - 12.2020
Nutrition Research Associate
Mathematica Policy Research
02.2020 - 03.2020
Lab Assistant
Grace Medical Center and Life Bridge Health
02.2018 - 02.2020
MASTER OF PUBLIC HEALTH - Epidemiology
GEORGE WASHINGTON UNIVERSITY
Bachelor of Science - Health Science
COPPIN STATE UNIVERSITY
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