LUKE HIGGINBOTHAM
Dayton,KY
Summary
Clinical Research Associate with 3 years of strong performance in site monitoring, regulatory compliance, and trial execution across nephrology, rare disease, neurology, and oncology. Recognized for data-driven decision-making, structured problem solving, and clear stakeholder communication. Committed to advancing within clinical operations while taking on broader strategic responsibilities and progressing into CRO leadership roles.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II
CTI Clinical Trial Services
- Current
- Served as the primary liaison for 18 sites, improving communication and resolving regulatory inquiries, enhancing operational efficiency.
- Conducted pre-study, initiation, interim, and close-out site visits, ensuring timely completion of deliverables while complying with regulatory requirements and GCP standards, including the first IMV for the largest clinical study in company history.
- Conducted feasibility assessments and selected sites for 5+ clinical trials, streamlining the project initiation process.
- Collect, review and track essential/regulatory documents.
- Participate in and complete all general and study specific training as required.
- Participate in investigator, client and project team meetings.
- Create and implement subject enrollment strategies for assigned study sites.
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials.
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager.
- Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan.
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP.
- Contributed to project tasks as a dedicated team member.
- May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.).
- May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures.
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
- Provide regular updates to Sponsor/ Client.
- Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments.
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
- Identify site issues and implement corrective actions or escalate as appropriate.
- Liaise with Clinical Data Management for data cleaning activities.
- Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary.
Clinical Research Associate I
CTI Clinical Trial Services
01.2023 - 01.2025
- Served as main CTI contact for assigned study sites.
- Conducted site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and completed site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP.
- Assisted with study start-up activities, including feasibility, pre-study activities and site selection.
- Collected, reviewed and tracked essential/regulatory documents.
- Participated in and completed all general and study specific training as required.
- Participated in investigator, client and project team meetings.
- Assisted in developing patient enrollment strategies with Project Team and study sites.
- Ensured proper storage.
Clinical Monitoring Associate
CTI Clinical Trial Services
01.2022 - 01.2023
- Performed on-site clinical trial monitoring, co-monitoring, and close-out activities, with oversight from project CRAs when required, while adhering to all applicable regulatory requirements and SOPs.
- May conduct independent on-site monitoring as sponsor requirements allow.
- Assisted project teams with study start-up activities, including site selection and phone Pre-Study Visits to identify and evaluate potential investigative sites.
- Collected, reviewed, filed, and tracked regulatory documents for investigative sites, when required, including assisting the project CRA with reconciliation of the TMF/eTMF.
- Participated in or conducted study specific training for CTI personnel or investigative sites.
- Attended Investigator or sponsor meetings.
- Assisted in development of monitoring tools for study, including remote monitoring checklist for eCRF studies.
- Conducted routine remote monitoring of eCRF studies, issuing queries in the database.
- Compiled monitoring visit packets and provided to project CRAs prior to on-site monitoring visits.
- Assisted in maintaining project-related tracking for CRA visit reports and letters, protocol deviations, serious adverse events (SAEs), and IND Safety reports.
- Contacted sites to ensure proper completion of monitoring / data management queries within timelines, resolution of action items related to Interim Monitoring Visits, and other site management tasks.
- Served as support / contact for CRA Team questions.
- Assisted with project-specific administrative activities as member of project team.
- Increased knowledge of drug development process, therapeutic areas, ICH / GCP, and any applicable local regulatory requirements.
Research Associate
CTI Clinical Trial Services
01.2021 - 01.2022
- Assisted in developing corporate overviews.
- Created professional binders for distribution to clients.
- Assisted in organizing, composing, and producing professional letters, summaries, reports, minutes, etc., using Microsoft Office software including Word, Access, and Excel.
- Proofread documents ensuring grammar, spelling, and punctuation are correct.
- Assisted in developing capability and training.
Education
Bachelor of Science - Biology
Ohio University
Athens, OH12.2020
Minor - Quantitative Business Analytics
Ohio University
Athens, OH12.2020
Skills
- Good Clinical Practice (GCP)
- Electronic Data Capture (EDC) systems
- Regulatory Compliance
- Leadership
- Client Communication
- Teamwork
- Site Monitoring
- Project Management
- Data Analysis
- Clinical Trial Management
- Problem Solving
- Site management
- Detailed documentation
Certification
CPR Certified (State of Ohio)
Timeline
Clinical Research Associate I
CTI Clinical Trial Services
01.2023 - 01.2025
Clinical Monitoring Associate
CTI Clinical Trial Services
01.2022 - 01.2023
Research Associate
CTI Clinical Trial Services
01.2021 - 01.2022
Clinical Research Associate II
CTI Clinical Trial Services
- Current
Bachelor of Science - Biology
Ohio University
Minor - Quantitative Business Analytics
Ohio University