Rufus J. Flomo
Summary
Clinical Research Professional with strong background in IRB regulatory submission and Clinical trial coordination. Adept at navigating complex clinical trial projects and regulatory frameworks as well as adherence to GCP and FDA guidelines. Facilitate effective communication with clinical trial sponsors, principal investigators, internal stakeholders, and IRB representatives. Known for fostering team collaboration, and driving successful outcomes. Skilled in clinical trial documentation, trial master file management, and risk assessment. Skilled at collecting, preparing, processing and shipping of research specimens. Committed to advancing medical research and improving human health.
Overview
3
3
years of professional experience
Work History
Clinical Trial & Regulatory Coordinator
BIOMEDICAL RESEARCH AND EDUCATION FOUNDATION OF SO. ARIZONA, – SOUTHERN ARIZONA VA HEALTH CARE SYSTEM (SAVAHCS)
07.2023 - Current
- Coordinating clinical trial project activities; management of clinical trial project resources and equipment. General understanding of clinical trial project budgeting using CPT Codes to determine standard vs non-standard of care.
- Present oral reports of project progress/status to Tucson VA-Administrative Officer (AO) and the Associate Chief of Staff (ACOS) for research and research team members during weekly meetings.
- Prepare and submit various regulatory documents (including Informed Consent Documents) to the Institutional Review Board (IRB); Maintains various project related reports and regulatory documents in project archive (Investigator Site File). Proficient at administrating IP subcutaneously (administering injections)
- Demonstrate clinical project leadership by Serving as a point-of-contact for Principal Investigators (PIs), Clinical Research Associates (CRAs), and IRB representatives.
- Develop, prepare, and timely submit clinical trial project documents to regulatory committees for study continuing reviews; perform data entry tasks and timely response to project data queries.
- Multi-task between different study projects to ensure the management of project timeline.
- Coordinate with clinical data management team to ensure queries are resolved in a timely manner in Sponsor’s clinical trial management systems (CTMS).
- Demonstrate clinical project leadership by leading studies startup to studies closed out visits (COV).
- Demonstrate clinical trial project leadership by coordinating with Investigational Pharmacists in ensuring IPs accountabilities and proper storage maintenance.
Clinical Research Coordinator I (CRC)
SYNEXUS/AES, A DIVISION OF THERMO FISHER SCIENTIFIC, INC
04.2022 - 05.2023
- Demonstrate leadership by Serving as a Team Lead on a phase III RSV Vaccine trial project.
- Worked closely with Clinical Research Associate (CRA) during Interim Monitoring Visits (IMVs).
- Extensive knowledge of clinical trial data management and queries resolutions in Medidata (EDC RAVE). Extensive knowledge of data management in clinical trial systems such as StudyHub and eCOA (electronic clinical outcome assessment).
- Independently capable of conducting screening visits for study start-ups. Experienced with Site Initiation Visits (SIVs).
- Experienced with multiples Clinical Trial Management Systems (CTMS), including Clinical Conductor (CC), and (e-Regulatory system).
- Knowledgeable in the application of ICH/GCP guidelines and other applicable IRB/IEC and FDA regulations.
- Filed study documents accordingly in the site investigator binder and e-regulatory folders.
- Present oral reports of study progress to principal investigators
- Performed in-house quality check (QC) on teammate work.
Education
MBA -
Grand Canyon University
Phoenix, AZ07-2024
Bachelor of Science - Biochemistry
The University of Arizona
12.2020
Associate of Applied Science -
Maricopa Community Colleges, Chandler-Gilbert Community College
Chandler, AZ05.2017
Skills
- Proficient at MS excel for data manipulation and/or data analysis
- Excellent skills in presentation development using MS PowerPoint
- Proficiency in MS Outlook and SharePoint
- Proficiency in MS Word usage for formatting document MEMOs and reports
- Develop a work breakdown structure for Clinical trials protocols
- Attention to detail
- Proficient in Adobe Acrobat Pro (prepare and format documents for security digital signatures)
- Document control
- Regulatory submissions
- GCP compliance
- Regulatory policies
- Multitasking Abilities
- Project management
Training
- Trained in regulatory submissions with Advarra, WGC, and institutional IRB like VA Central IRB-Panel 3
- Trained in Good Clinical Practice (GCP) and Human Subject Research (HSR)
- Trained in Clinical Trial administrative duties
Timeline
Clinical Trial & Regulatory Coordinator
BIOMEDICAL RESEARCH AND EDUCATION FOUNDATION OF SO. ARIZONA, – SOUTHERN ARIZONA VA HEALTH CARE SYSTEM (SAVAHCS)
07.2023 - Current
Clinical Research Coordinator I (CRC)
SYNEXUS/AES, A DIVISION OF THERMO FISHER SCIENTIFIC, INC
04.2022 - 05.2023
MBA -
Grand Canyon University
Bachelor of Science - Biochemistry
The University of Arizona
Associate of Applied Science -
Maricopa Community Colleges, Chandler-Gilbert Community College
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