Faustina Opoku
Canal Winchester,OH
Summary
Experienced Program Manager skilled in managing functional operations and projects related to supplies and logistics. Advanced understanding of organizational strategies, financial management, procurement and contracting. Expertise in logistical analysis, inventory and supply chain performance, development and standardization. Thorough understanding of inventory management, procurement and acquisition regulations.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Research Protection Program Manager
U.S. Air Force Research Laboratory, AFRL, RG, AFWERX
04.2022 - Current
- Manages human subjects/animal use research protections technical review and administrative processing of research proposals, contracts, and other agreements within AFWERX
- Manages and evaluates contract proposals, statements of work, and/or research proposals seeking Department of Defense funding/awards and coordinates such efforts with principal investigators, IRBs, IACUCs, AF Human Research Protection Official (HRPO)
- Develops, plans, hosts, and deliver HRPP/IACUC training and education materials in various venues such as web-site materials, workshops, training presentations, and quality assurance visits and discussions related to human research protections official administrative processing
- Develops and maintains standard operation procedures (SOPs) within AFWERX related to human subject research methodologies
- Collaborates with small business companies (SBC’s) in complying with the SBIR/STTR funding related to human subject research regulatory compliance
- Develops and maintains AFRL human research/ animal use protections compliance databases and web-based systems for administrative management of tracking and documenting human research protections.
Snr. Clinical Research Coordinator/ Specialist
The Ohio State University – College of Nursing
02.2017 - 04.2022
- Executed and coordinated community, clinic-based and hospital-based clinical research projects
- Coordinated in the writing of grant proposals and the acquisition of support from outside agencies, while assisting with the development of new and revised research methodologies
- Developed and coordinated with the Institutional Review Board (IRB) for research proposals and review IRB, review result notices, noncompliance investigations, and other related official correspondence, while maintaining/updating SOPs
- Oversaw data collection, data entry under the guidance of the Principal Investigator (PI) and safeguarded the integrity of study data
- Ensured consent process was administered in compliance with regulatory and sponsor requirements, while educating patients and families of purpose, goals, and processes of clinical trials
- Supported all research activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations by coordinating and preparing for external quality assurance and control reviews by the IRB, federal or industry sponsors, while participating in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.
Lead Clinical Research Assistant / Clinical Trials Office
The Ohio State University, James Cancer Hospital
06.2015 - 01.2017
- Collected and provided data used for assessing patient eligibility as well as toxicity reporting
- Followed protocol design to assure all protocol data elements are collected in accordance with protocol guidelines
- Made computer and manual entries from information abstracted from patient charts on EPIC/IHIS, Medidata RAVE, CTSU etc
- Entered required protocol and patient information into Cancer Research Information System (CRIS).
Education
Master of Science - Clinical Research Management
The Ohio State University
Bachelor of Science - Healthcare Administration/Systems
Kent State University
Skills
- Problem-Solving
- Project Management
- Detail Oriented
- Strategic Planning
- Team leadership and direction
- Process Improvement
Accomplishments
- Collaborated with team of 10 in the development of creating a compliance plan for my division.
- Resolved product issue through consumer testing.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
References
References Furnished Upon Request.
Certification
- PgMP - Program Management Professional
- ACRP - Association of Clinical Research Professionals
- Clinical Research Management Training - 02/2020
- Regulatory Compliance Training - 01/2022
Timeline
Research Protection Program Manager
U.S. Air Force Research Laboratory, AFRL, RG, AFWERX
04.2022 - Current
Snr. Clinical Research Coordinator/ Specialist
The Ohio State University – College of Nursing
02.2017 - 04.2022
Lead Clinical Research Assistant / Clinical Trials Office
The Ohio State University, James Cancer Hospital
06.2015 - 01.2017
Master of Science - Clinical Research Management
The Ohio State University
Bachelor of Science - Healthcare Administration/Systems
Kent State University
- PgMP - Program Management Professional
- ACRP - Association of Clinical Research Professionals
- Clinical Research Management Training - 02/2020
- Regulatory Compliance Training - 01/2022
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