ALISHA W. MCCART
Stone Mountain,GA
Summary
Clinical Research Professional with over 4 years of experience coordinating and supporting Phase I-IV clinical trials within academic medical centers and sponsor organizations. Extensive knowledge of ICH-GCP, FDA regulations, protocol compliance, informed consent, participant enrollment, regulatory documentation, data management, and sponsor interactions. Experienced collaborating with investigators, CROs, pharmaceuticals, sponsors, and multidisciplinary research teams to ensure participant safety, data integrity, and successful study execution. Therapeutic expertise includes neurology, epilepsy, rare disease, oncology, cardiovascular disease, sleep medicine, bone marrow transplantation, blood disorders, and chronic disease research. Seeking to leverage strong clinical operations and site management experience into a Clinical Research Associate role.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Trial Navigator
Praxis Precision Medicines
Boston
01.2025 - Current
- Serve as primary liaison between clinical trial participants, investigative sites, principal investigators, and sponsor teams across multiple U.S. study locations.
- Support participant enrollment activities while ensuring compliance with study protocols and informed consent requirements.
- Coordinate communication among study stakeholders to facilitate protocol adherence and participant retention.
- Track participant progress and maintain accurate clinical trial documentation in accordance with GCP guidelines.
- Collaborate with cross-functional teams to identify and resolve enrollment and operational challenges.
- Maintain detailed records of participant interactions and protocol-related activities.
- Support study execution through effective communication, issue escalation, and participant advocacy.
- Managed 2 studies with enrollment over 250 participants
- Managed over 15 clinical sites across the US and streamlined participants to the appropriate location for screening.
- Collaborated with cross-functional teams to streamline processes and enhance operational efficiency.
- Evaluated navigation tools and systems, recommending improvements for user experience and functionality.
- Facilitated communication between stakeholders, ensuring clarity on study objectives and participant needs.
Clinical Research Coordinator
Children's Healthcare of Atlanta
Atlanta
09.2023 - 01.2025
- Coordinated clinical research activities for pediatric studies while ensuring protocol compliance and participant safety.
- Assisted with development and maintenance of source documents and Case Report Forms (CRFs).
- Conducted participant screening, enrollment, study visits, and protocol-required assessments.
- Obtained informed consent in accordance with institutional, regulatory, and sponsor requirements.
- Participated in sponsor correspondence, monitoring visits, and study team meetings.
- Maintained regulatory binders and essential study documentation in audit-ready condition.
- Supported data management activities, query resolution, and quality control initiatives.
- Scheduled study visits and coordinated research procedures with ancillary departments.
- Monitored compliance throughout study conduct and escalated issues as appropriate.
- Educated participants and families regarding study requirements and protocol procedures.
- Primary coordinator of 9 studies simultaneously
- Developed and maintained study documentation and regulatory submissions for audits.
- Collaborated with multidisciplinary teams to streamline operational workflows and improve efficiency.
- Trained and mentored junior staff on best practices in clinical research protocols.
- Analyzed trial data to identify trends, informing strategic decision-making for ongoing research initiatives.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Gathered, processed, and shipped lab specimens.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
Clinical Research Coordinator I
Emory University School of Nursing – Wharton Lab
Atlanta
03.2022 - 07.2023
- Maintained compliance with ICH-GCP, HIPAA, institutional policies, SOPs, and study-specific procedures.
- Conducted participant recruitment, screening, informed consent, enrollment, and retention activities.
- Performed protocol-specific efficacy and safety assessments, vital signs, venipuncture, cognitive testing, and specimen collection.
- Coordinated participant visits, diagnostic testing, and protocol-required procedures.
- Collaborated with investigators and study teams to manage day-to-day study operations and protocol implementation.
- Maintained regulatory files and study documentation in audit-ready condition.
- Assisted with protocol amendments, continuing reviews, and regulatory submissions.
- Processed, packaged, tracked, and shipped biological specimens in compliance with study and regulatory requirements.
- Supported sponsor communications, compliance reporting, and study performance metrics.
- Contributed to community outreach initiatives to improve clinical trial awareness and participant engagement.
- Trained junior staff on best practices in clinical research protocols and ethical guidelines.
- Led project meetings to discuss progress, address challenges, and align team objectives effectively.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Registration Associate / EPIC Super User
Children's Healthcare of Atlanta
Atlanta
03.2019 - 02.2022
- Coordinated patient scheduling and insurance verification for high-volume specialty services.
- Managed eligibility review, prior authorizations, and patient communications.
- Supported operational workflows and process improvement initiatives.
- Served as EPIC Super User, providing training and support to staff members.
- Coordinated team meetings and maintained accurate documentation and reporting.
- Registered over 300 patients weekly
- Streamlined patient registration processes, enhancing efficiency and reducing wait times.
- Managed electronic health record updates to ensure accuracy and compliance with healthcare regulations.
- Collaborated with interdisciplinary teams to coordinate patient services and improve care delivery.
- Trained and mentored new staff on registration procedures and system functionalities.
- Developed training materials for staff development, focusing on best practices in patient registration and service excellence.
- Led initiatives to enhance patient experience, addressing concerns and improving satisfaction ratings through feedback analysis.
Registration Associate
Gwinnett Medical Center
Atlanta
11.2016 - 11.2018
- Managed patient registration, insurance verification, and documentation review.
- Conducted detailed information gathering and compliance verification.
- Maintained accurate patient records and ensured data integrity.
- Supported patient access and administrative operations in a fast-paced healthcare environment.
- Registered over 200 emergency patients.
- Facilitated patient registration processes to ensure accurate data entry and compliance with healthcare regulations.
- Coordinated communication between departments to resolve patient inquiries and improve service delivery.
- Developed and maintained electronic health record (EHR) accuracy, contributing to improved patient care continuity.
- Enhanced patient experience by providing empathetic support during the registration process, fostering a welcoming environment.
- Maintained strict confidentiality of patient information in compliance with HIPAA regulations.
- Resolved patient inquiries regarding registration procedures, alleviating concerns and promoting a positive experience.
- Coordinated with other departments such as billing and admissions to ensure seamless transfer of patient information throughout their treatment journey within the facility.
Firefighter II / EMT-I
DeKalb County Fire Rescue
Atlanta
04.2009 - 07.2015
- Delivered emergency medical care and maintained comprehensive patient documentation.
- Coordinated emergency response activities and trained personnel on operational procedures.
- Developed strong communication, leadership, and critical-thinking skills in high-pressure situations.
- Responded to emergency incidents, providing critical support and ensuring safety of team and public.
- Conducted fire suppression strategies, mitigating risks and protecting property from fire damage.
- Collaborated with local agencies on community outreach programs, enhancing public awareness of fire safety practices.
- Trained new recruits in firefighting techniques and safety protocols, fostering a culture of learning and preparedness.
- Developed and implemented standard operating procedures for emergency response, improving efficiency during operations.
- Led incident command during complex emergencies, coordinating multi-agency responses to enhance operational effectiveness.
- Analyzed post-incident reports to identify areas for improvement, driving strategic changes in training and response tactics.
- Assisted in wildfire suppression efforts by coordinating with local, state, and federal agencies to establish containment lines and protect threatened structures.
Education
Master of Public Health - Public Health
University of Phoenix
Phoenix, AZ01-2022
Bachelor of Science - Health Administration
University of Phoenix
Phoenix, AZ01-2020
Associate of Arts - Health Care Administration/Management
University of Phoenix
Phoenix, AZ01-2017
Skills
- ICH-GCP Compliance
- Clinical Trial Operations
- Site Management & Oversight
- Source Documentation Review
- Study Start-Up & Maintenance
- Monitoring Visit Support
- Subject Recruitment & Retention
- Data Management & Quality Assurance
- Query Resolution
- Adverse Event Documentation
- Laboratory Sample Management
- Audit & Inspection Readiness
- Adverse event reporting
- Clinical data management
- Patient retention strategies
- Site initiation visits
- Data safety monitoring
- Detailed documentation
Certification
- Good Clinical Practice (GCP) & ICH Certification
- Human Subjects Protection – Biomedical Research
- Clinical Research Coordinator Training
- Health Privacy & Information Security
- Shipping & Transport of Biological Materials
- Research Laboratory Safety
- CPR/BLS Certified
- Phlebotomy Certified
PUBLICATIONS
Butts, B., Hu, W. T., Verble, D. D., Likos, K. D. S., Bliwise, D. L., Trotti, L. M., Benameur, K., McCart, A. W., Cook, J. A., Hammerschlag III, B. L., Nimmagadda, N., Russ, A. D., Wharton W., Relationships between excessive daytime sleepiness and arterial stiffness with cognitive function in a racially diverse high-risk cohort., Alzheimer's Association International Conference, 07/2023, Amsterdam
Timeline
Clinical Trial Navigator
Praxis Precision Medicines
01.2025 - Current
Clinical Research Coordinator
Children's Healthcare of Atlanta
09.2023 - 01.2025
Clinical Research Coordinator I
Emory University School of Nursing – Wharton Lab
03.2022 - 07.2023
Registration Associate / EPIC Super User
Children's Healthcare of Atlanta
03.2019 - 02.2022
Registration Associate
Gwinnett Medical Center
11.2016 - 11.2018
Firefighter II / EMT-I
DeKalb County Fire Rescue
04.2009 - 07.2015
Master of Public Health - Public Health
University of Phoenix
Bachelor of Science - Health Administration
University of Phoenix
Associate of Arts - Health Care Administration/Management
University of Phoenix