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 status • Reviews site recruitment plans and takes action to drive recruitment in collaboration with the site staff on an ongoing basis • Reviews and follows up regarding site payments • Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training • Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required

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• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and 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• Is available as a resource for protocol requirements for research staff and investigators• Provides feedback and updates to the research associate and teamRegulatory Coordination• Completes IRB application, reports and correspondence timely and accurately• Processes, prepares, and submits IRB submissions, including new study approval, amendments, continuing reviews, final reports, IND safety reports, and other study notifications that require IRB submission• Processes protocol deviation reports• Maintains credential files for investigators and research staff• Maintains departmental regulatory documents per accepted standards • Follows good clinical practice guidelines• Stays current and informed with changes in regulatory guidelines• Report regulatory compliance infractions to the appropriate partyData Management• Creates databases for clinical trial• Verifies data to insure compliance with protocol criteria• Enters or transcribes data into the database according to schedule within protocol and contractual requirements• Develops and implements data management plan designed to meet project and protocol deadlines• Extracts data information for reports to assist with data analysis• Participates in study management processes• Tracks progress of clinical trial

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 involving stroke patients. In working with the physician and other research staff, we designed research studies to test the effectiveness of a relatively new, non-invasive neuro-monitoring device in the neuroICU setting.Skills and Experience:• Prospective/retrospective protocol design• Grant proposal • IRB Submissions• Clinical trial study start up• Patient screening and data collection • Develop and maintain database of subject information • Assisting with data analysis• Presentation of research findings• Significant interaction with patients and healthcare providersAwards and Recognitions:• Abstract publication to the Journal of Neurocritical Care Abstract Supplement 2012 (October 2012)• Abstract accepted for poster presentation to the 10th annual Neurocritical Care Society Annual Conference in Denver, Colorado (October 2012)• Two abstracts accepted for poster presentations to Mayo Clinic Florida’s Stroke and Cerebrovascular Disease Review (September 2012) • Oral presentation to the Neurocritical Care Conference at Mayo Clinic on the topic of Near-infrared Spectroscopy (February 2012)• Abstract publication to the Journal of Neurocritical Care Abstract Supplement 2011 • Abstract accepted for poster presentation to the 9th annual Neurocritical Care Society Annual Conference in Montreal, Canada (September 2011)Publications:1. New approaches to bedside monitoring in stroke. Cyrous A, O'Neal B, Freeman WD. Expert Rev Neurother. 2012 Aug; 12(8):915-28. 2. Validation of frontal near-infrared spectroscopy as noninvasive bedside monitoring for regional cerebral blood flow in brain-injured patients. Taussky P, O'Neal B, Daugherty WP, Luke S, Thorpe D, Pooley RA, Evans C, Hanel RA, Freeman WD. Neurosurg Focus. 2012 Feb; 32(2):E2.

Master Of Science - Ms, Biotechnology

Bachelor Of Science - Bs, Biological And Biomedical Sciences