Brandon O'Neal Email & Phone Number

San Diego, CA, US

Marlborough, MA, US

San Diego, California, US

• Operating as study manager and CRA to provide successful management of prospective multi-center study in HR+ breast cancer patients
• Manage clinical studies and serve as primary liaison with principal investigators and sites to ensure adherence to protocols, GCP, ICH and SOPs.
• Responsible for all aspects of study management, including training, conduct of pre-study and initiation visits, monitoring, maintenance of study files, close-out of sites, and other duties, as assigned.
• Independently perform CRF review, query generation and resolution against data review guidelines on data management systems.
• Participate in the development of study protocols and Case Report Forms.
• Assist in the writing and review of study reports, scientific and regulatory submissions, and SOPs, prepare and present clinical data at scientific/board meetings as needed.

Leopardstown, Dublin, IE

• Clinical Research Associate providing Global One services to Sanofi Clinical Study Unit
• Lead CRA on pivotal Phase III Advanced Metastatic breast cancer study including 10+ CRAs
• Clinical site's primary point of contact from qualification to close-out
• CRA Mentor and Team Leader
• Study Vendor management
• Generate study status reports and management of CRA team

Leopardstown, Dublin, IE

• Clinical Research Associate providing Global One services to Sanofi Clinical Study Unit
• Phase I - III Oncology Trial Management
• Clinical site's primary point of contact from qualification to close-out
• CRA Mentor and Systems Expert

Durham, North Carolina, US

• Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial
• Oversees conduct of trial at designated sites to ensure rights and well-being of subjects are protected
• Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements.
• Conducts Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generates contact and site visit reports in compliance with the monitoring plan
• Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents. Assesses & manages test article/study supply including supply, accountability and destruction/return.
• Reviews site recruitment plans and takes action to drive recruitment in collaboration with the site staff on an ongoing basis

Durham, North Carolina, US

• Conduct country specific feasibility and/or site pre-qualification
• Review and validate site identification list
• Collect and negotiate Confidentially Agreements (CDAs)
• Organize translations per country/regulatory/client requirements
• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP)
• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments

San Diego, California, US

• Study Coordination
• Coordinates and participates in site qualification and site initiation visits with the sponsor, PI, and applicable research staff
• Provides assistance with clinical trial study start up to include assisting with feasibility assessment, ARCIS approval, IRB approval and/or laboratory set-up
• Assists with study maintenance including following scheduled events, scheduling meetings/appointments and/or tracking study changes/enrollment
• Creates study binders to organize events and activities with the study
• Works in collaboration with the PI and research nurse to fulfill the protocol requirements

Rochester, Minnesota, US

• I was accepted by Mayo Clinic as a research assistant under Dr. William Freeman in the department of neurology intensive care. I aided in institutional review board (IRB) approved investigator initiated studies.
• Prospective/retrospective protocol design
• Grant proposal
• IRB Submissions
• Clinical trial study start up
• Patient screening and data collection

Master Of Science - Ms, Biotechnology

Bachelor Of Science - Bs, Biological And Biomedical Sciences