Dionne Brown Apedjihoun MS., CCRP
Clinical Research Project Manager (Remote) at Precia Group- Claim this Profile
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Bio
Karen K.
Dionne wholeheartedly dedicated her vision for the CDC Project Firstline training focus on Urban Indian Organization capacity and COVID health disparities in American Indian/Alaska Native communities. She tirelessly drove the team towards this common purpose, relentless on clarity, value-add, and impact working alongside native community partners. As a Subject Matter Expert at the intersection of infection control, sociology, and cultural anthropology, I was fortunate to observe her leadership at work.
Karen K.
Dionne wholeheartedly dedicated her vision for the CDC Project Firstline training focus on Urban Indian Organization capacity and COVID health disparities in American Indian/Alaska Native communities. She tirelessly drove the team towards this common purpose, relentless on clarity, value-add, and impact working alongside native community partners. As a Subject Matter Expert at the intersection of infection control, sociology, and cultural anthropology, I was fortunate to observe her leadership at work.
Karen K.
Dionne wholeheartedly dedicated her vision for the CDC Project Firstline training focus on Urban Indian Organization capacity and COVID health disparities in American Indian/Alaska Native communities. She tirelessly drove the team towards this common purpose, relentless on clarity, value-add, and impact working alongside native community partners. As a Subject Matter Expert at the intersection of infection control, sociology, and cultural anthropology, I was fortunate to observe her leadership at work.
Karen K.
Dionne wholeheartedly dedicated her vision for the CDC Project Firstline training focus on Urban Indian Organization capacity and COVID health disparities in American Indian/Alaska Native communities. She tirelessly drove the team towards this common purpose, relentless on clarity, value-add, and impact working alongside native community partners. As a Subject Matter Expert at the intersection of infection control, sociology, and cultural anthropology, I was fortunate to observe her leadership at work.
Credentials
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Overcoming Your Fear of Public Speaking
LinkedInOct, 2017- Sep, 2024 -
Certified Clinical Research Professional - SOCRA
SoCRA
Experience
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Precia Group
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United States
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Research
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1 - 100 Employee
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Clinical Research Project Manager (Remote)
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Oct 2022 - Present
Through Medix™, working with PreciaGroup, a Contract Research Organization (CRO) addressing gender bias in clinical trials by expanding the number of women, especially those from underrepresented populations, in research studies to establish management systems and develop strategies to optimize clinical research operations across the network of community hospitals. Main responsibility is to oversee multiple clinical trials conducted across the network, working closely with the Principal Investigator, site research lead, research staff, and Sponsors to ensure that each study is conducted properly per protocol and Good Clinical Practice and is meeting recruitment targets. Specific duties include, overseeing the process of study startup, protocol implementation, data management/monitoring and study close out; developing and maintaining research procedures with the goal of standardization, increased efficiency, and ensuring quality and integrity of all clinical trials, operating in accordance with all applicable regulatory and compliance guidelines; overseeing clinical research coordinators across the Network sites and working closely with local PIs and research leadership towards programmatic goals; developing scope of work and performance metrics for each new project; working closely with Network sites to identify/maintain staffing requirements and recruitment strategies and providing input to CEO on client proposals including, deliverables, timelines, and budget as well as managing clinical research monitoring activities.
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Senior Project Manager (Remote)
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Jun 2020 - Sep 2022
Worked remotely to oversee a team responsible for NCUIH’s Infection Prevention and Control Training program in collaboration with the Centers for Disease Control and Prevention's Training and Educational Initiative, Project Firstline. Primarily responsible for ensuring compliance while supporting the monitoring and reporting of the project to the Sponsor. Primary objective is geared towards supporting the development, implementation, evaluation and dissemination of a multi-faceted training program specific to the Urban Indian Organization's health and public health workforce. Main responsibilities include (a) Providing oversight to ensure success of NCUIH’s Infection Prevention and Control (IPC) Training for the UIO Workforce initiative and (b) Supervising the IPC Training Project team (c) Implementing the Workplan.
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Elligo Health Research
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Study Manager, Research Operations (Hybrid)
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Jun 2017 - Apr 2020
Worked remotely and on site to facilitate Elligo’s direct to patient model to streamline patient identification and qualification, site activation, patient enrollment, study initiation and study conclusion within the practices of Community Physician; Pre-study, site qualification, study initiation, monitoring visits, and study close out activities. Responsible for coordinating IRB approved protocol related research procedures, study visits, and follow- up care across a region; tracking key study metrics and providing timely and quality updates; Educate subjects and family on protocol, study intervention, and study drug. Assist with the development and management of company-wide Electronic Regulatory database. Provide back-up coverage for National sites. Support Patient Engagement and Project Management Teams. Developed Pre-screening and Outreach documentation for the IntElligo Research Stack application on multiple studies in various indications. Oversaw and managed the QC process for the upload of Pre-screening/Outreach documentation and query results data to the IntElligo Research Stack Application.
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IMMUNOe Health & Research Centers
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United States
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Medical Practices
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1 - 100 Employee
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Clinical Research Coordinator
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May 2018 - Aug 2018
Lead CRC on certain studies; involved in all aspects of clinical trials research from pre-study planning to study completion and included direct involvement in case management of study participants. Responsible for the overall management and completion of all aspects of Clinical Research as well as -- assisted in developing internal marketing materials following internal guidelines; recruited and retained patients through appropriate measures; conducted and completed study visits; performed safety assessments including, vital signs, ECG, etc.; created and maintained source documentation; completed Case Report Forms and managed query resolution; maintained essential documents in the regulatory binder. Additional responsibility included, creating documentation in compliance with all regulatory requirements; organizing, facilitating, and implementing research activities across multiple studies of different therapeutic areas and phases; preparing for and attending site initiation meetings, as well as interim monitoring and closeout visits; attending sponsor Investigator / Coordinator meetings as needed for assigned protocols and participating in peer review of data quality.
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Children's Hospital Colorado
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United States
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator II/Children's Oncology Group (COG) CRA
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Mar 2015 - May 2017
At Children’s Hospital Network of Care location in Colorado Springs, I was responsible for the coordination of multiple phases of PI initiated, Federal and Industry sponsored Clinical Trials in collaboration with the Principal Investigator as well as the COG (Children’s Oncology Group) Studies. Tasks Included planning, developing, recording, collaborating and reporting of data and follow-up activities as required by the contract and sponsoring agent. COMIRB, BLS/CPR certified and knowledgeable in research consent, protocol and IRB submission guidelines and documentation. Versed in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. With a focus on COG Clinical Trials, I was responsible for Record and Research Subject Management, performance of research tests and procedures, shipment of biological samples and reports as well as serving as a contact person for ongoing clinical research studies globally. Meet with representatives from sponsoring organizations or in-house staff for initial orientation to studies and for review of study records.
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Duke University Medical Center
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator II
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Jun 2013 - Dec 2014
Managed the Implementation and Coordination of DoD funded Multisite trial and trained counterpart to launch study at their site (Walter Reed National Military Medical Center); worked within the Durham VA Hospital (WOC) and Duke University Medical Center (DUMC) systems and liaise with USAMRMC-HRPO and the FDA (obtain IND exemption) to secure study approval; managed clinical research protocol documents and activities from initial submission to continuing reviews at both sites. Responsible for the continued development and revisions to the protocol, research summary, consent form template and source documentation worksheets; coordinated with REDCap personnel for the continued development and revisions to the electronic Case Report Form (eCRF). Coordinated and participated in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data; assisted in the determination of guidelines for the collection of clinical data and/or administration of clinical studies; coordinated and implemented procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; obtain blood samples, and other specimens for laboratory analyses. Ensured compliance with protocol guidelines and requirements of regulatory agencies and assisted in the preparation of SOPS, amendments to protocols and/or modifications to study design as appropriate. Conferred with principal investigator(s) to assist in developing plans for research projects and to discuss the interpretation of results. Assisted with the drafting and submission of progress reports to USAMRMC-HRPO (U.S. Army Medical Research and Materiel Command - Human Research Protection Office) for continued funding.
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University of Miami
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United States
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Higher Education
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700 & Above Employee
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Clinical Research Coordinator
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Jan 2007 - May 2012
Coordinated all aspects of Industry-Sponsored and Investigator- Initiated phases I, II, III & IV clinical trials. Liaised with the University’s Legal Department - CRIS office (CRIS – Clinical Research Initiation Services) for contract negotiations and Institutional Review Boards (Local IRB and CIRB) and assisted with the submission of Research Protocols, Amendments, Reportable Events, Continuing Reviews and Study Close-Out procedures. Recruited, Obtained Informed Consent from, Screened and Enrolled Research Participants onto research trial. Facilitated communication between the Principal Investigator, other site personnel, and research participants. Reviewed charts and electronic medical records; abstracted data and maintained EDC; resolved data queries and conducted data verification. Responsible for, compilation, registration and submission of data; protocol initiation, contract review, to study completion; study participant safety and confidentiality and adherence to study protocol to ensure Safety and Health Administration (OSHA), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) are followed; coordination of study participant/family progress through protocol. Utilized Specific Research Software to manage clinical trials. Procured, organized and managed clinical research contracts and activities on device or drug related study protocols; Liaised with the University’s Legal department with budget reviews and assisted with contract negotiations on clinical trials and community based participatory research project - HEATITUP (Health Education Access Through Information Technology Utilization Project). Coordinated UHF Initiatives (Diabetes, Access to Healthcare, Mental health, Functional Assessment, HIV, OB,) at the Jefferson Reaves Sr. Health Center to create a Center of Excellence. Coordinated quality assessment and quality improvement audits; Managed, coordinated and supervised research support.
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Jamaica Broilers Group Limited
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Jamaica
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Food Production
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300 - 400 Employee
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Quality Control Officer
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Jan 1998 - Mar 2002
JAMAICA BROILER’S GROUP LTD. Jamaica W.I. Jan. 1998 – Mar.2002 QUALITY CONTROL OFFICER (CONTENT DIVISION) Sept. 2001 – Mar 2002 SNR. QUALITY CONTROL TECH. /BRAND REP. (BDC DIVISION) Jan. 1998 – Sept.2001 Managed Quality Control, Sanitation, Pest Control and Laundry Departments; Executed Quality Assurance, Quality Control, Food Safety and Pest Control programs; Organized and Implemented HACCP (Hazard Analysis Critical Control Point) Training Program for Managers and Supervisors; Conducted Performance Appraisals for Supervisors and Staff of requisite Departments; Participated in Product Development and Troubleshooting. Maintained Product Integrity through Quality Assurance/Quality Control Program; Liaised with Fast Food Customers and Parent Company to ensure Product Quality and Product supply; Received and Process Customer Complaints; Established Corrective Actions; Developed Standard Operating Procedures for Entire Plant Operations. Developed Training Manuals; Executed Training Programs; Supervised Departmental Employees.
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Education
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Barry University
Master of Science - MS, Biomedical Sciences -
The University of the West Indies, Mona
Bachelor of Science - BS, Biochemistry and Zoology Double Major -
University of Miami
Certificate in Healthcare Administration -
University of Miami - School of Business
Graduate Certificate in Business Management
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