Brandi Antonio, M.S., ACRP-CP
Research Administrator II
Hilo,HI
Summary
ACRP-certified Clinical Research Professional with over 2 years of Phase 1, 2, and 3 global clinical trial experience and over 5 years of non-clinical research experience. Versed in SOP, ICH-GCP guidelines, quality control, project management and clinical operations. Superior time management, organization, administrative skills, and collaboration contributing to optimal patient care and workplace initiatives.
Overview
7
7
years of professional experience
9
9
years of post-secondary education
1
1
Certification
Work History
Research Administrator II
University Of California At Davis
Sacramento, CA
03.2023 - Current
- Perform quality control on 50% of Cancer Center's oncology clinical trial calendars to ensure proper billing, finances, and adherence to protocol requirements for execution of multi-million dollar data migration project.
- Utilize OnCore CTMS platform to build study calendars inclusive of coverage analysis and finances for oncology industry, investigator-initiated and federal clinical trials.
- Identify and extrapolate important information from research protocols, Medicare Coverage Analysis (MCA) documents and Clinical Trial Agreements (CTA) to be incorporated into OnCore study calendars.
- Collaborate with Assistant Director of Cancer Center's Business Unit and colleagues on meeting project deadlines, while working independently on assigned projects.
- Partner with Clinical Research Coordinators and CTMS companies to verify protocol and essential documents for publication to Cancer Center's CTMS
Clinical Research Coordinator
East-West Medical Research Institute
Honolulu, HI
07.2022 - 02.2023
- Managed assigned clinical trials, maintain electronic databases, and oversee clinical trial systems (EDC, IWRS, CTMS) for 80% of site protocols.
- Collated relevant study information and documents in preparation for 5-10 CRA visits per month, including site initiation visits, in-person and remote monitoring visits, audits, and Investigator Meetings.
- Developed and modified trial-specific source documents in collaboration with Trial Manager and Clinical Operations Manager.
- Performed quality control of clinical data, source documentation, case report forms (CRFs), and regulatory documents for 20-25 active trials, simultaneously.
- Completed and submitted regulatory documents for Trial Master File (TMF) such as IRB submissions, Form 1572, and Financial Disclosure Form for study start-up and compile documents for close-out activities.
- Reconciled generated queries and discrepancies identified by sponsor or CRO.
- Reported and documented Adverse Events and Protocol Deviations according to Standard Operating Procedures and study protocol.
- Collaborated with 7 research teams, 4 Investigators, and 3 Managers to meet enrollment goals and provide administrative support for site projects and day-to-day operations.
Clinical Research Assistant
East-West Medical Research Institute
Honolulu, HI
01.2021 - 06.2022
- Assisted 6 Clinical Research Coordinators with maintaining TMF, electronic CRF data entry, drug accountability, and IWRS/IRT transactions.
- Collected data in accordance to research protocols, operations manuals, and CRF requirements.
- Utilized electronic documentation systems to input clinical trial data, process patient requests, and maintain inventory of study materials.
- Ensured adherence to study protocol, site SOP, and ICH/GCP guidelines by resolving 100% of queries prior to monitor visits.
- Initiated email correspondence with 11 sponsors and CRAs to provide clinical data and ensure proper compliance with protocol.
- Communicated written and oral instructions to 400-500 patients about medications and study procedures to patients in professional and positive manner.
Graduate Research and Teaching Assistant
University Of Hawaii At Manoa
Honolulu, HI
03.2016 - 12.2020
- Oversaw and taught 7 undergraduate laboratory courses in introductory microbiology, senior level microbiology, and clinical microbiology for 150 students.
- Prepared curriculum according to course objectives and deepened student understanding of subject matter.
- Collaborated with professors to evaluate student progress and resolve concerns.
- Utilized online platforms to communicate and educate students.
- Prepared and presented tables, spreadsheets, and graphs summarizing research.
Education
Master of Science - Microbiology
University of Hawaii At Manoa
Honolulu, HI 08.2015 - 12.2020
Bachelor of Arts - Biology
University of Hawaii At Hilo
Hilo, HI 08.2011 - 08.2015
Skills
Trial Master File management
Microsoft Office (Word, Powerpoint, Excel, Outlook)
GCP and ICH principles
Excellent organization and time management
Interpersonal skills
Accountable
Independent and collaborative in team environment
Strong oral and written communication
Multitasking and prioritizing tasks
Project Management
Clinical Trial Management Systems (EDC, eCRF, IWRS)
Certification
Association of Clinical Research Professionals - Certified Professional
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Far and away the best prize that life offers is the chance to work hard at work worth doing.
Theodore Roosevelt
Timeline
Research Administrator II
University Of California At Davis
03.2023 - Current
Association of Clinical Research Professionals - Certified Professional
08-2022
Clinical Research Coordinator
East-West Medical Research Institute
07.2022 - 02.2023
Clinical Research Assistant
East-West Medical Research Institute
01.2021 - 06.2022
Graduate Research and Teaching Assistant
University Of Hawaii At Manoa
03.2016 - 12.2020
Master of Science - Microbiology
University of Hawaii At Manoa
08.2015 - 12.2020
Bachelor of Arts - Biology
University of Hawaii At Hilo
08.2011 - 08.2015