Staci Bouasenesouk
Santa Fe,TX
Summary
15-year clinical research coordinator and 8 years regulatory experience with solid background and extensive skills in the field of Oncology and Medical Device. Detailed-oriented with management and leadership and well organized 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 strong work ethic.
Logical and perceptive professional with several years of experience leading research focused on studying diseases and other factors to improve human health. Instrumental in conducting clinical investigations, research and development the field. Seasoned professional proficient in wide variety of laboratory procedures and data analysis.
Overview
22
22
years of professional experience
Work History
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 on Good Clinical Practice (GCP), Human Subject Protection (HSP), and Health Insurance Portability and Accountability Act (HIPAA) compliant and department Standard Operating Procedures (SOPs).
- Submit regulatory documents through MDACC IRB, WCG IRB, and CIRB.
- Interacts and communicates with 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 compensations.
- Responsible for annual Continuing Reviews and reporting new information to MDACC IRBs, WCG IRB, and CIRB.
- Updated Investigators and clinical research staff on 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, Principle 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 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
NivaLova (Medical Device)
02.2002 - 07.2007
- Managed epilepsy, anxiety, and depression trials (vagus nerve stimulator).
- 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, customer service, filing records, prepared memos, correspondence, reports, spreadsheets, and other documents.
Education
Bachelor of Science - Health Information Management
University of Phoenix
Associate of Science -
University of Arlington
San Jacinto College, Houston
Skills
- Project Management
- Data Management
- Analytics and research
- Knowledge of federal and local regulations, policies related to research involving human subjects
- P>Strong focus on teamwork, attention to detail, excellent organizational and problem solving
- Proficient in Microsoft Applications
- Clinical Study Design
- Study Budgeting
- Administration and management
- Attention to Detail
- Informed Consent Process
- Study Closeout Procedures
- Protocol development
- Clinical Data Management
- Good clinical practice
- Training and mentoring
- IRB Submissions
- Clinical trial management
- Clinical Research Coordination
- Decision-Making
- Problem-solving aptitude
- Research management
- Teamwork and Collaboration
Affiliations
Member of Association of Clinical Research Professional (ACRP). Member of Society of Clinical Research Organization (SOCRA).
Additional Information
- Nominated for the Julie and Ben Rogers Award for Excellence on August 14, 2012.
- Awarded for MD Anderson Cancer Center Division of Cancer Medicine - Citation for Excellence Clinical on April 05, 2012.
- LivaLova (neuromodulation devices and cardiopulmonary products) - Awarded for Depression PMA FDA submission in 2003.
- Volunteered at Brookdale Senior Living in Webster, TX from 2010-2015.
- Volunteered at Memorial Hermann Southeast Hospital for Surgical & Rehab Therapy, Houston, TX from 2015-2016.
Timeline
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
NivaLova (Medical Device)
02.2002 - 07.2007
Bachelor of Science - Health Information Management
University of Phoenix
Associate of Science -
University of Arlington
San Jacinto College, Houston
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