Tiffany Dunbar
Houston,TX
Summary
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Regulatory Compliance Coordinator
Dept. of Palliative, Rehabilitation, and Integrative Medicine (PRIM)
Houston, TX
04.2023 - Current
- Establish and maintain a system for development of research program, including writing, processing, Submit new retrospective/prospective studies and protocol modifications in the electronic systems by the SRC/IRB deadlines and follow through to IRB approval and activation
- Ensure that all reviews are addressed to the satisfaction of the reviewers by working with the PI and study team
- Manage the electronic tracking system for all protocol-related documents
- Prepare, draft, and budgets protocols and grant submissions for the Palliative, rehabilitation, and Integrative Medicine sections
- Attend and prepare the study start-up and investigator meetings
- Collect and develop criteria information for protocol submission
- Identify deviations or violations for submission to IRB
- Update departmental protocol list for weekly review by Admin Dir, Protocol Research
- Coordinates clinical trial audits, monitors visits, and other quality assurance activities
- Create MTAs, submit contracts, and follow through in MTA and RCT systems
- Assist with submission of continuing reviews and related protocol changes
- Serves as a liaison between the clinical research departments, study sponsors, Clinical Research Organizations (CROs), and federal agencies
- Ensure regulatory compliance with federal, state and local laws and policies related to institutionally sponsored clinical research
- Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.)
- Develop patient care methodology for protocols, including criteria for patient participation
- Coordinate FDA/IND audits and submissions, as well as internal audits (Clinical Research Support Center)
- Develop and assist with writing and proofreading of protocols and grant proposals, including grammar and proper English
- Order study-related materials for research protocols
- Serves as a resource to others who participate in the protocol and grant process
- Maintain database for internal and external protocol and grant submissions
- Ensure/track training compliance for research staff and key personnel with Good Clinical Research Practice standards and Human Subjects Protection Training
- Orient new faculty and support personnel on department’s clinical trials research infrastructure and procedures
- Disseminate pertinent information to other team members
Senior Research Compliance Anaylst
Office Of Research
Houston, TX
05.2020 - 04.2023
- Reviewed standards and all applicable regulations and accreditation standards concerning human and animal research
- Managed two research conflict of interest employees and set up weekly meetings to go over agenda items ensure compliance and provide guidance and coordination in regard to regulatory and accrediting bodies
- maintained and offered ethical and regulatory guidance in the changing research environment
- Applied institutional policies and federal, state, and local regulations regarding the conduct of human and animal research
- Identified teams to develop BCM procedure and provide guidance for human and animal research regulatory and accreditation standards
- Established a call center to address research compliance questions and concerns
- Communicated College policy to departmental personnel, responded to policy questions, and developed internal procedures to ensure compliance with policy
- Planned and organized a variety of projects directly related to the departmental goals
- Collaborated with team members to ensure completion of mutual performance goals
- Conducted assessments on late disclosures of Significant Financial interests and subsequent relation to funded research
- I interacted with and provided information to the Research Conflict of Interest Committee
- Routinely audited financial conflict of interest management plans to ensure compliance with PHS regulations
- Conducted scientific overlap analysis on funded research
- Prepared management plans for Investigators based on the committee’s determinations Finalized meeting minutes after the research conflict of interest meetings
- Reviewed and monitored compliance with applicable laws, regulations, and policies to ensure compliance with regulatory requirements.
- Developed training materials for personnel regarding compliance standards and procedures.
- Coordinated with internal stakeholders to ensure adherence to relevant rules and regulations.
- Drafted reports outlining findings from investigations into non-compliance incidents.
- Monitored changes in legislation that could affect the organization's operations.
- Participated in meetings with external auditors regarding audit results related to compliance matters.
- Maintained an up-to-date knowledge base of all relevant laws, regulations, guidelines, and industry standards.
- Collaborated with various departments within the organization to develop effective solutions for ensuring ongoing compliance.
- Implemented corrective action plans when necessary following the discovery of non-compliance issues.
- Tracked progress towards meeting established goals related to organizational compliance objectives.
- Created plans to improve and correct operations in order to stay compliant.
- Helped to investigate fraud and identify risks in collaboration with risk management staff.
- Produced reports outlining assessments completed and follow-up recommendations.
- Issued official approvals in instances where they achieved or exceeded compliance standards.
Senior Research Conflict of Interest Analyst
Office Of Research
Houston, TX
05.2017 - 05.2020
- Project Management of the Day-to-Day Research Conflict of Interest job duties
- Trained new Research Conflict of Interest staff
- Reviewed protocols and proposals in BRAIN
- Reviewed Annual Financial Disclosures
- Supported the Research Conflict of Interest Board once a month by conducting a monthly committee meeting
- Prepared monthly meeting agenda Prepared meeting minutes
- Established anticipated quorum for each monthly meeting
- Prepared Financial Conflict of Interest review packets for committee board members to review
- Assured key RCOI issues are discussed in full board meeting
- Prepared management plans for Investigators based on the committee board members determinations
- Provided RCOI customer service and education to Staff, Administrative contacts, and Investigators
- Conducted RCOI assurance check for the Institutional Review Board (IRB) and Sponsored Programs (SPO) and issued assurance letter approvals based on RCOI policies and procedures guidelines
- Train and recommend RCOI solutions to Staff, Administrative contacts, and Investigators
- Provided analytical and programmatic support to the Research Conflict of Interest program
- Reviewed and filed Memorandums of Understanding
- Assisted in developing a comprehensive database management system.
- Performed quality assurance to assess the data and validate the results.
- Developed actionable roadmaps for improving workflows and processes.
- Conducted detailed analysis on key trends and findings to summarize findings for leadership.
- Conducted workplace compliance training to reduce liability risks.
Research Data Coordinator – Breast Medical Oncology
The University of MD Anderson
Houston, TX
12.2015 - 05.2017
- Project Management Performed key changes, manipulation of data, abstracting data from one database to another database, and updating of data in several clinical databases
- Contributed to the compilation, organization, and production of protocols, clinical study reports, or other controlled documentation
- Monitored study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
- Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
- Maintained contact with sponsors to schedule and coordinate site visits and answer questions about issues such as incomplete data
- I contacted outside health care providers and communicated with subjects to obtain follow-up information
- Tracked enrollment status of subjects and document dropout information, such as dropout causes and subject contact efforts
Research Data Coordinator – Department of Leukemia
The University of MD Anderson
Houston, TX
07.2014 - 12.2015
- Project management and administration duties
- Assisted in maintaining uniform and standardized policies and procedures for the clinical trial data process, which meet Good Clinical Practice (GCP)
- Maintained required records of study activity, including case report forms, drug dispensation records, adverse event logs, and regulatory forms
- Performed quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data
- Handled the tasks of updating and reviewing data in the clinical databases based on query resolutions I attended the clinic with study manager to oversee study enrollment process
- Welcomed new data coordinators
- Collected and reviewed study data.
- Assessed the records of each patient, reviewed databases, and checked referrals to locate potential research study participants.
- Maintained confidentiality of all collected data as per the organization's policies and guidelines.
Education
Certificate - Foundations of Leadership
The National Society of Leadership And Success
01.2022
Master's Degree - Business Administration
Strayer University
Washington, DCBachelor's Degree - Health Care Administration
UNIVERSITY OF PHOENIX
Associates Degree - Business
UNIVERSITY OF PHOENIX
Certificate of Project Management
University of Phoenix
Tempe, AZCertificate of Health Care Informatics
University of Phoenix
Tempe, AZSkills
- Compliance Reporting
- Document Reviews
- Audit Oversight
- Audit Support
- Regulatory Issues
- Conducting Investigations
- Process Development
- Process Management
- Investigative Skills
- Data Evaluation
- Program Implementation
- Regulatory Compliance Oversight
- Training Coordination
- Regulatory Documentation
- Policy Enforcement
- Information Gathering
- Document Analysis
- Risk Reviews
- Quality Controls
- Internal Audits
- System Development
- System Management
- Audits Management
Certification
- Certificate, 2021 - 2022, THE NATIONAL SOCIETY OF LEADERSHIP AND SUCCESS, Foundations of Leadership
- Certificate, 2021 - 2022, UNIVERSITY OF PHOENIX, Project Management
- Certificate, 2014 - 2014, UNIVERSITY OF PHOENIX, Health Care Informatics
Accomplishments
- A member of The National Society of Leadership and Success
References
References available upon request.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
If the doors of perception were cleaned, everything would appear to man as it is: infinite.
William Blake
Timeline
Regulatory Compliance Coordinator
Dept. of Palliative, Rehabilitation, and Integrative Medicine (PRIM)
04.2023 - Current
Senior Research Compliance Anaylst
Office Of Research
05.2020 - 04.2023
Senior Research Conflict of Interest Analyst
Office Of Research
05.2017 - 05.2020
Research Data Coordinator – Breast Medical Oncology
The University of MD Anderson
12.2015 - 05.2017
Research Data Coordinator – Department of Leukemia
The University of MD Anderson
07.2014 - 12.2015
Certificate - Foundations of Leadership
The National Society of Leadership And Success
Master's Degree - Business Administration
Strayer University
Bachelor's Degree - Health Care Administration
UNIVERSITY OF PHOENIX
Associates Degree - Business
UNIVERSITY OF PHOENIX
Certificate of Project Management
University of Phoenix
Certificate of Health Care Informatics
University of Phoenix
- Certificate, 2021 - 2022, THE NATIONAL SOCIETY OF LEADERSHIP AND SUCCESS, Foundations of Leadership
- Certificate, 2021 - 2022, UNIVERSITY OF PHOENIX, Project Management
- Certificate, 2014 - 2014, UNIVERSITY OF PHOENIX, Health Care Informatics
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