Mayah N. Haynes, MHA
NC, USA
Overview
7
7
years of professional experience
1
1
Certification
Work History
Social/Clinical Research Specialist: Hematology/Oncology
East Carolina University
Greenville, NC
03.2023 - Current
- Led financial operations serving as the primary finance personnel for multiple Phase 2-4 clinical trials, negotiating and managing budgets in line with ECU guidelines to ensure financial sustainability.
- Conducted comprehensive coverage analyses and reviewed trial documents for accurate budget submissions and ongoing trial activities.
- Developed and submitted internal budget documentation for sponsor approval and fund creation.
- Managed trial funding, overseeing accurate time/effort reporting and ensuring compliance and operational efficiency.
- Coordinated study start-up, preparing and submitting regulatory documents to the IRB for timely approval.
- Managed study submissions in the ePIRATE portal for efficient IRB review and approval.
- Modified regulatory documents, including Informed Consent Forms and FDA 1572, incorporating required University language while ensuring compliance with 45 C.F.R. 46 federal regulations.
- Participated in site selection, training, and ensuring GCP adherence throughout the study phases.
Customer Assistance Specialist
ThermoFisher Scientific (PPD)
Morrisville, NC
04.2022 - 03.2023
- Delivered high-quality customer service to clients, including patients, HCPs, and client personnel.
- Documented interactions per guidelines, identifying adverse events and potential concerns.
- Maintained knowledge of policies, SOPs, GCPs, and regulatory requirements for compliance.
- Processed medical information requests via email, fax, and mail.
- Coordinated patient appointments and supported the initiation of newly FDA-approved drugs.
- Served as the primary point of contact for patients, providing medication and treatment support.
- Collected patient data on medication effectiveness and satisfaction for clinical trials.
- Ensured compliance with FDA regulations, GCP, and HIPAA in patient record management.
Clinical Research Analyst
WCG Clinical
Cary, NC
05.2021 - 09.2021
- Interpreted Medicare/Medicaid coverage decisions and national guidelines to determine which procedures are billed to sponsors and which to Medicare/private insurance.
- Conducted coverage analysis for clinical research, identifying study-related and routine care procedures to ensure proper billing and compliance with payer requirements.
- Coded procedures per CPT/HCPCS guidelines and applied appropriate research modifiers for accurate claims submission.
- Developed and negotiated clinical trial budgets and coverage analyses based on client’s preferred pricing methodologies.
- Built and managed studies within the client’s clinical trial management system (CTMS) for efficient tracking and reporting.
Microbiology Quality Control Assistant Analyst
GlaxoSmithKline
Zebulon, NC
05.2018 - 08.2018
- Assisted Lead Analysts in conducting microbiology tests and assays, ensuring precise and reliable results.
- Collected and tested daily samples from production areas, following strict quality control and safety protocols.
- Ensured proper handling, processing, and disposal of biological specimens in compliance with laboratory guidelines.
- Documented and analyzed test results, identifying any deviations and recommending corrective actions.
- Maintained cleanliness and calibration of lab equipment to ensure accuracy and prevent contamination.
Education
Master of Healthcare Administration -
UNC Wilmington
Wilmington, NC05.2023
BS - Public Health (Global)
UNC Wilmington
Wilmington, NC12.2020
Skills
- Process Improvement
- Stakeholder Interaction
- Vendor & CRO Liaison
- Good Clinical Practice (GCP)
- Study Start-Up Coordination
- Regulatory Compliance
- Timeline Management
- Clinical Trial Documentation
- Clinical Trial Management Systems (CTMS)
- Microsoft Excel
- Communication
- Site Monitoring Visit Preparation
- Team collaboration
- Therapeutic area expertise
Certification
- Good Clinical Practice for Clinical Trials Involving Investigational Drugs, CITI, 03/01/23, 03/31/26
- Human Research: All Biomedical Investigators and Key Personnel, CITI, 03/01/23, 03/31/26
- Ageism First Aid, The Gerontological Society of America (GSA), 11/01/22, 11/30/25
- Excel Fundamentals - Formulas for Finance, Corporate Finance Institute (CFI), 12/01/22, Present
Timeline
Social/Clinical Research Specialist: Hematology/Oncology
East Carolina University
03.2023 - Current
Customer Assistance Specialist
ThermoFisher Scientific (PPD)
04.2022 - 03.2023
Clinical Research Analyst
WCG Clinical
05.2021 - 09.2021
Microbiology Quality Control Assistant Analyst
GlaxoSmithKline
05.2018 - 08.2018
Master of Healthcare Administration -
UNC Wilmington
BS - Public Health (Global)
UNC Wilmington
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