Tonisha Brown
CHARLOTTE,NC
Summary
Results-driven Project Manager experienced in guiding teams and managing complex initiatives. Achieved alignment with organizational goals through development of efficient processes and proactive problem-solving. Focused on delivering positive outcomes and enhancing team performance in fast-paced environments.
Overview
1
1
Certification
17
17
years of professional experience
Work History
Director, Clinical Research
Atrium Health
Charlotte, NC
10.2019 - Current
- Managed clinical research initiatives covering study execution, protocol alignment, and progression toward improved patient care and treatment protocols.
- Created, rolled out, and maintained study protocols aligned with regulatory requirements.
- Directed multidisciplinary teams to coordinate workstreams and track progress toward project timelines and objectives.
- Directed data management workflows, ensuring accurate records and integrity of research findings.
- Partnered with stakeholders to align research goals with organizational strategies by mapping research priorities to strategic objectives.
- Analyzed clinical trial workflows, streamlined operational processes, and implemented data management systems to improve data handling and trial execution efficiency.
- Streamlined study delivery by aligning cross-functional stakeholders through effective communication and collaborative execution.
- Partnered with Legal to strengthen legal review processes supporting clinical operations and improving contract administrations.
- Managed recruitment planning and execution for clinical trials, aligning patient outreach strategies to strict inclusion criteria and diverse population targeting goals.
- Owned end-to-end data quality initiatives across clinical trials, enhancing data integrity for more accurate analyses and actionable insights.
- Assessed regulatory submission requirements and provided expert guidance to enable approval of investigational products for human use.
- Operationally applied communication and leadership skills to drive execution of team member development plans.
- Oversaw complex budgeting for concurrent studies, aligning funding and resource allocation to maximize return on investment.
- Established partnerships with external experts and institutions to increase access to research resources and expand organization research capabilities.
- Defined clear, compelling goals for research teammates to support efficient research execution and monitored productivity and output to maintain operational alignment.
- Negotiated and managed vendor contracts to support ongoing service delivery with timely execution, competitive pricing, and high-quality standards.
- Drove efforts to maintain Quality Assurance program through routine audits and timely corrective actions as needed to support operational compliance.
- Worked directly with the Finance Department to prepare accurate financial statements supporting clinical research operations and maintaining enterprise-wide visibility into financial impact.
- Presented findings at national conference to share knowledge with peers and stay current on advanced developments within the field.
- Recruited and hired staff, delivered comprehensive training, and maintained direct supervision; managed ongoing development and continuing education for teammates.
- Authored and revised ongoing policy and procedure updates, ensuring continuous alignment with applicable compliance guidelines.
- Created and introduced structured leadership development coaching and team management model, defining coaching approach and team management practices to enable promotion into expanded responsibility.
- Authored, reviewed, and maintained pharmacy management policies and procedures to guide effective investigational product operations.
Research Manager, Pediatrics
Atrium Health
Charlotte, NC
08.2017 - 10.2019
- Managed end-to-end research initiatives focused on evaluating clinical outcomes and informing patient care strategy development.
- Designed and implemented data collection protocols to support adherence to regulatory standards.
- Partnered with cross-functional teams to analyze research findings and support decision-making processes.
- Managed cross-functional teams to complete complex research projects on time and within budget for operational planning.
- Streamlined data collection and analysis processes to increase research efficiency.
- Designed project management tools to track progress, enable team communication, and help ensure timely completion of assigned tasks.
- Oversaw budgets across multiple concurrent research projects to support research objectives, ensuring careful resource allocation and fiscal responsibility.
- Developed and maintained research-community relationships to enable collaborative opportunities for upcoming projects.
- Managed regular project update meetings by presenting detailed project status across timelines, deliverables, risks/issues, and action items.
- Assessed deliverables against quality, ethical, and compliance criteria while confirming alignment with project specifications.
- Ensured adherence to approved budget guidelines by monitoring expenses and submitting timely financial reports.
RN Program Coordinator
Carolinas HealthCare
Charlotte, NC
07.2016 - 08.2017
- Administered investigational products, medications, and treatments, following established protocol requirements to maintain participant safety and compliance.
- Collaborated with interdisciplinary teams to implement individualized care plans for diverse patient populations.
- Monitored patient progress, documented condition changes, and responded promptly to emergencies as needed.
- Provided health management education to support comprehension of treatment plans, research protocols, and adoption of self-care practices.
- Executed detailed patient assessments to monitor for changes in condition, promptly communicating findings to the PI.
- Administered investigational product per protocol while closely monitoring for adverse events.
- Completed ongoing continuous professional development to maintain currency on evolving best practices in nursing care and clinical research.
- Conducted thorough assessments, documenting changes in patient conditions for accurate reporting.
- Coordinated end-to-end submission workflows for consent development and amendment protocol amendments, ensuring timely processing of continuing review closure, accrual action letter suspension, termination activities, and other reportable regulatory documentation.
- Facilitated timely coordination of documentation submissions with regulatory team and study personnel to optimize workflow efficiency.
Identified critical regulatory updates through comprehensive reviews of NCI research base and sponsor websites, driving necessary actions.
Senior Clinical Research Coordinator
Raleigh Neurology Associates P.A.
Raleigh, NC
01.2011 - 03.2016
- Coordinated cross-functional clinical trial operations, monitoring adherence to regulatory requirements and protocol-specific procedures.
- Maintained study documentation lifecycle, ensuring accurate data records and compliance alignment.
- Analyzed study participant recruitment and retention workflows and implemented improvements to increase operational efficiency.
- Facilitated information flow between site personnel, investigators, and sponsors to maintain alignment during trial process.
- Increased patient retention rates by establishing strong participant relationships to support ongoing engagement through effective communication and follow-up.
- Diligently monitored adverse events throughout clinical trials and escalated emerging safety concerns promptly for appropriate review.
- Conducted study visits and maintained protocol compliance with ICH/GCP standards and FDA regulatory requirements.
- Screened patient records and physician referrals to identify prospective research study candidates.
- Executed informed consent procedures and maintained complete, up-to-date records for audit readiness.
- Collected data, ensured adherence to research protocols, and completed required case report forms aligned with operations manual requirements.
Clinical Submission Specialist
PPD
Durham, NC
03.2010 - 01.2011
- Developed and implemented standard operating procedures that improved efficiency in regulatory compliance processes.
- Monitored project timelines and budgets, ensuring adherence to organizational standards and client expectations.
- Maintained database systems to track and analyze operational data.
- Owned the ICF negotiation process with investigators, research nurses, and site administrative staff to support compliance with ICH-GCP, PPD, and sponsor requirements, and coordinated dissemination with the legal department.
- Reviewed regulatory documents for adherence to FDA GCP, WPD and SOPs, then managed transmission following site IRB approval.
- Coordinated essential document collection and review to support ICF review and Central IRB submission processes.
Education
Bachelor of Science - Nursing
North Carolina Central University
Durham, NCSkills
- Project management
- Operations management
- Budget management
- Financial analysis
- Strategic planning
- Business strategy
- Decision-making
- People management
- Talent acquisition
- Problem-solving
- Organizational skills
- Operational efficiency
- Relationship building
Accomplishments
- Supervised team of [Number] staff members.
Affiliations
Member of Association of Clinical Research Professionals
Charlotte Chapter
President Elect 2020-2023
President 2023-2024
Certification
Certified , September 2013 – current
- North Carolina Registered Nurse License #206453
- Certified Clinical Research Coordinator, Association of Clinical Research Professionals - 2013-current
Timeline
Director, Clinical Research
Atrium Health
10.2019 - Current
Research Manager, Pediatrics
Atrium Health
08.2017 - 10.2019
RN Program Coordinator
Carolinas HealthCare
07.2016 - 08.2017
Senior Clinical Research Coordinator
Raleigh Neurology Associates P.A.
01.2011 - 03.2016
Clinical Submission Specialist
PPD
03.2010 - 01.2011
Bachelor of Science - Nursing
North Carolina Central University