STACI BOUASENESOUK
Houston,TX
Summary
15-year clinical research coordinator and 8 years of regulatory experience with a solid background and extensive skills in the field of Oncology and Medical Devices. Detail-oriented with management and leadership, well organized, and with strong multi-tasking skills. A versatile team player who enjoys assisting others. Strong interpersonal and customer service skills. Organized Office Manager with noted experience in administrative management. Prioritize projects and multitask effectively to achieve project goals. Methodical and detail-oriented team player with expertise in team leadership. Offering these skills and a strong work ethic. Logical and perceptive professional with several years of experience leading research on studying diseases and other factors to improve human health. Instrumental in conducting clinical investigations, research, and development in the field. Seasoned professional proficient in a wide variety of laboratory procedures and data analysis.
Overview
1
1
Certification
24
24
years of professional experience
Work History
IRB/IACUC Coordinator
UTMB-Galveston OB/GYN RSU
09.2024 - Current
- Participated in initiation visits and investigator meetings.
- Managed central and local IRB submissions for all NIH, NRN, MFMU Network, Industry-sponsored, and investigator-initiated studies.
- Interpreted and applied regulatory guidelines established by UTMB IRB.
- Self-trained and proficient in OnCore and InfoEd portals.
- Proficient in leveraging multiple external initial site application systems for study start-up activities.
- Ensured laboratory compliance in preparation for upcoming inspections.
- Developed and executed a migration plan to relocate 68,000 regulatory documents from S: Drive to SharePoint.
- Conducted quality assurance reviews for regulatory documents in SharePoint and Regulatory/ISF binders.
- Responsible for writing Standard Operating Procedures (SOPs).
- Delivered weekly IRB/regulatory training sessions for research staff, covering regulations, policies, and procedures.
- Collaborated on drafting recruitment processes and telephone scripts.
- Scheduled meetings for the Associate Director.
- Attended budget and contract meetings.
- Managed research staff travel reimbursements, ClinCards (Greenphire), and procurement of departmental and study-related supplies via POWER.
- Process all invoices.
- Maintained records of departmental monthly charges.
- Oversaw research staff timekeeping in Kronos.
- Ensure timely reimbursement for participant parking expenses.
- Provide weekly educational training for all Research Staff.
Clinical Research Regulatory
Diabetes And Glandular Disease Research Clinic
06.2023 - 12.2023
- Collaborated with cross-functional teams to ensure seamless execution of clinical studies, resulting in successful project completion.
- Identified areas for improvement in existing processes through robust audits, leading to increased operational efficiency in subsequent studies.
- Played a key role in budget and grant applications, crafting compelling proposals that underscored the significance and potential impact of proposed research projects.
- Improved clinical trial efficiency by developing and implementing streamlined processes for data collection and analysis.
- Provided expert guidance to junior team members on best practices in clinical research, contributing to their professional development and growth within the organization.
- Improved policy and expanded knowledge of health care and human service systems.
Sr. Clinical Research Program - Regulatory
The University of Texas MD Anderson Cancer Center
09.2015 - 01.2023
- Managed >/=100 Genitourinary protocols from initial to closing/termination.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Reviewed and prepared regulatory documentation packets for initial submissions: MDACC Institutional Review Board (IRB), FDA, Western Copernicus Group (WCG) IRB, and Central IRB (CIRB).
- Monitored the completeness and quality of Regulatory documentation, including Medical Licenses, CVs, 1572, and Financial Disclosure forms (FDFs).
- Ensure clinical staff and doctors are trained in Good Clinical Practice (GCP), Human Subject Protection (HSP), and Health Insurance Portability and Accountability Act (HIPAA) compliance, as well as department Standard Operating Procedures (SOPs).
- Submit regulatory documents through MDACC IRB, WCG IRB, and CIRB.
- Interacts and communicates with the Scientific Review Committee (SRC), Investigational Pharmacy, and MDACC IRB for new protocol submissions.
- Reviewed and negotiated Informed Consent (ICFs) by MDACC Consent Editors to ensure accurate information, such as site address (if applicable), side effects, and financial compensation.
- Responsible for annual Continuing Reviews and reporting new information to MDACC IRBs, WCG IRB, and CIRB.
- Updated Investigators and clinical research staff on the status of IRB submissions and resubmissions, review, approval, and regulatory documents.
- Responsible for resolving monitor regulatory queries.
- Tracked and filed documents and maintained communication between clients to manage office activities.
- Conducted meetings with Clinical Protocol Teams: Research nurses, Data Team, Principal Investigators (PI), and Sponsors to discuss/review protocol logistics and amendments.
- Assisted with edits to protocols.
- Maintained regulatory documents in e-Reg filing via BOX, SharePoint, Teams, and file cabinets.
- Created training and Delegation of Authority (DOAs) in Prometheus.
- Tracked and managed new submissions: Protocol activation within 100 days from initial submission to IRB approval.
- QA protocols for internal (MDACC) or external audits: MDACC internal Monitors, Sponsors, and FDA.
- Participated in audits.
- Participated in committees to discuss electronic health records and new system methods to improve overall workflows.
- Assigned as Super User for Dept.
- Responsible for completing and submitting annual Continuing Reviews via MDACC IRB, WCG IRB, CIRB, and Data Safety Monitoring Board Review reports.
- Prepared agenda and notes at PI meetings to archive proceedings.
- Coached colleagues through day-to-day work and complex problems.
- Office coverage for the Manager.
- Worked effectively in fast-paced environments.
Clinical Research Data Specialist
The University of Texas MD Anderson Cancer Center
04.2008 - 08.2015
- Assessed patients/participants for eligibility through personal interviews and medical records review for early stage prostate cancer protocol (Active Surveillance (AS)).
- Managed >/=1,000 patients for AS protocol.
- Provided educational needs regarding protocol appointments and procedures for patients.
- Consented potential patients.
- Registered patients into the Institutional database, Clinical Oncology Research (CORe), and departmental database Prometheus.
- Followed up with patients according to protocol to monitor compliance per protocol guidelines.
- Responsible for accurate and timely transcription of study notes into EPIC.
- Ensures accurate, confidential, and complete compilation of data.
- Responsible for tracking and recording deviations, violations, adverse events, and other study-related activities.
- Review patient's record regarding visits and schedule study procedures.
- Provided study timelines, project assumptions and ongoing updates in Data Coordinator Meetings with Primary Investigators.
- Tracked key study metrics using tracking tools: Excel sheets and dept database Prometheus
- Adhered to Good Clinical Practices (GCP), Human Subject Protection (HSP), and Heath Insurance Portability and Accountability Act (HIPAA) compliant, and departmental Standard Operating Procedures (SOPs).
- Assists with monitoring audits/visits for protocols.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Learned and adapted quickly to new technology and software applications.
Health Information Management - System Analyst
The University of Texas MD Anderson Cancer Center
08.2007 - 03.2008
- Provided application support and troubleshooting for Forms Anywhere application issues.
- Oversaw test plan development, application testing and installations.
- Developed, document and revised system design procedures, test procedures, and quality standards.
- Consulted with management to ensure agreement on system principles.
- Troubleshooted program and system malfunctions to restore normal functioning.
- Provided staff and users with assistance solving computer-related problems, such as malfunctions, and program problems.
- Assisted in training of new employees on company policies, procedures and processes.
- Helped meet changing demands by recommending improvements to business systems or procedures.
Clinical Data Manager
LivaNova (Medical Device)
02.2002 - 07.2007
- Managed epilepsy, anxiety, and depression trials.
- Primary responsibilities included: Setting up databases, generating reports of clinical trials; processes data using range of computer applications and database systems to support collection, cleaning, and management of patient data.
- Ensured complete, accurate and consistent data for reporting to Study Directors, Director of Biostatistician, Clinical Scientists, and Clinical Sites as needed to ensure completeness and quality of all clinical data.
- Facilitated in development of protocols and other study-related documents case report forms (CRFs)
- Generate reports for statistical analysis.
- Analyzed and presented data to clinical staff, manager, and physicians.
- Perform extensive internal and external quality control checks on data on regular basis and formal documentation of any issues.
- Assisted with database management plans and provided input on study designs.
- Trained employees on new database systems and procedures.
- Other duties included: answering and directing phone calls, providing customer service, filing records, preparing memos, correspondence, reports, spreadsheets, and other documents.
Education
Bachelor of Applied Arts and Science - Health Information Management
University of Phoenix
Skills
- Project Management
- Analytics and research
- Knowledge of federal and local regulations, policies related to research involving human subjects
- Strong focus on teamwork, attention to detail, excellent organizational and problem solving
- Proficient in Microsoft Applications
- Study Budgeting
- Administration and management
- Informed Consent Process
- Protocol development
- Good clinical practice
- Training and mentoring
- Clinical Research Coordination
- Decision-Making
- Problem-solving aptitude
- Research management
- Teamwork and Collaboration
- Time management abilities
- Organizational Skills
- Excellent Communication
- Analytical Thinking
- Interpersonal Communication
Accomplishments
- Supervised team of [Number] staff members.
Certification
- CITI Good Clinical Practice (GCP) – Current
- CITI Human Subjects Protection (HSP) – Current
- CITI Human Subjects Research (IRB) training – Current
- Basic Life Support – Current
- Biosafety Level-2 – Current
ACTIVITIES
- Member of the Association of Clinical Research Professionals (ACRP)
- Member of the Society of Clinical Research Organizations (SOCRA)
- Member of Public Responsibility in Medicine and Research (PRIM&R) - I am currently pursuing certification as a Certified IRB Professional (CIP).
Languages
English
Timeline
IRB/IACUC Coordinator
UTMB-Galveston OB/GYN RSU
09.2024 - Current
Clinical Research Regulatory
Diabetes And Glandular Disease Research Clinic
06.2023 - 12.2023
Sr. Clinical Research Program - Regulatory
The University of Texas MD Anderson Cancer Center
09.2015 - 01.2023
Clinical Research Data Specialist
The University of Texas MD Anderson Cancer Center
04.2008 - 08.2015
Health Information Management - System Analyst
The University of Texas MD Anderson Cancer Center
08.2007 - 03.2008
Clinical Data Manager
LivaNova (Medical Device)
02.2002 - 07.2007
Bachelor of Applied Arts and Science - Health Information Management
University of Phoenix