Crystal Gatling
Greensboro,NC
Summary
Results-driven Clinical Operations leader with 12 years of experience in optimizing clinical trials. Successfully maintained FDA inspection-ready documentation while mentoring CRAs to improve site performance and team effectiveness. Known for developing action plans that enhance efficiency and ensure compliance across all operational aspects.
Overview
1
1
Certification
14
14
years of professional experience
Work History
Administrative Assistant
Mount Zion Baptist Church
Greensboro, NC
02.2025 - Current
- Manage executive calendars, scheduling, and multi-campus coordination.
- Tracked and disseminated weekly action items to ensure alignment within Executive Staff Team.
- Maintain confidentiality of sensitive information for senior leadership.
- Oversaw accuracy of membership data across Teachable and Ministry Platform to maintain up-to-date records.
- Supported facility management, engaged vendors, and facilitated community outreach to strengthen organizational relationships.
- Utilize Microsoft Excel, Outlook, OneNote, and Venus Control Suite for operational workflows. Tracked and resolved action items for Executive Staff Member Team weekly.
Partner Line Manager
PAREXEL International
Durham, NC
09.2022 - 07.2024
- Reviewed monitoring reports to identify site trends and enhance CRA performance.
- Ensured continuous inspection readiness of site and ISF documentation.
- Conducted risk assessments and developed proactive mitigation strategies.
- Monitored CRA metrics and established quality assurance measures to ensure compliance.
- Led communication with Clinical Operations, QA, Data Management, and external stakeholders.
- Proposed innovative solutions to address monitoring challenges and improve process efficiency. Analyzed monitoring reports to identify site trends and evaluate CRA performance.
Clinical Monitoring Manager
Advanced Clinical
Deerfield, IL
07.2021 - 09.2022
- Mentored Lead CRAs and CRAs, enhancing their professional growth and competency.
- Acted as SME for monitoring processes, regulations, and industry standards.
- Supported feasibility assessments and study start-up activities.
- Mentored Lead CRAs and CRAs, fostering professional growth and competency.
- Conducted employee evaluations, one-on-one meetings, and performance plans.
- Produced Monitoring Globe newsletter, improving team communication and engagement.
Manager of Clinical Operations
PRA Health Sciences / Sanofi Pharmaceuticals
Raleigh, NC
04.2017 - 07.2021
- Managed clinical projects from initiation to completion, ensuring timelines and budgets were met.
- Conducted quality checks and performance management to enhance staff development and project outcomes.
- Presented project bids while coordinating client account activities to align project goals with client expectations.
- Presented project bids and coordinated client account activities.
- Promoted collaborative team environment focused on achieving results and enhancing team cohesion.
Regional Senior Clinical Research Associate
PRA Health Sciences / Sanofi Pharmaceuticals
07.2015 - 04.2017
- Conducted feasibility, qualification, SIVs, RMVs, and COVs.
- Ensured timely SAE reporting within 24-hour requirements.
- Reconciled site files vs. TMF using site-specific trackers. Followed up on all SAE Reporting to ensure Serious events were conveyed…within the required 24-hour timeline.
- Performed remote EDC review, data reconciliation, and deviation management.
- Tracked site issues and trends, conducting root-cause analyses for escalation teams to facilitate timely resolutions.
- Reconciled site files with TMF using site-specific trackers to ensure compliance and accuracy. Followed up on SAE reporting to confirm serious events were communicated within required 24-hour timeline, ensuring regulatory compliance.
- Contributed to PAREXEL International projects
Regional Sr. Clinical Research Associate
Parexel International
Durham, NC
02.2012 - 06.2015
- Conducted site evaluations for clinical trial readiness and compliance.
- Ensured accuracy of electronic data capturing systems for integrity and compliance.
- Monitored trial progress and ensured adherence to protocols and regulations.
- Checked electronic data capturing systems for integrity and compliance.
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
- Collaborated with investigators to facilitate patient recruitment and retention strategies.
- Participated in audits to ensure adherence to Good Clinical Practice guidelines.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Cultivated relationships with vendors with external vendors to support trial operations effectively.
- Contributed to audits ensuring regulatory adherence to ensure adherence to Good Clinical Practice guidelines.
- Assisted in the development of informed consent documents according to local regulations.
Education
Master of Science - Legal Sciences
Kaplan University
Indianapolis, INBachelor of Science - Zoology (Pre-Med)
North Carolina State University
Raleigh, NCSkills
- Office management
- Project coordination
- Regulatory compliance
- Team support
- Quality assurance
- Research support
- TMF/eTMF management
- Document organization
- Action planning
- Data management
- Supplier coordination
- Medidata Rave and Oracle Clinical
- Database management
- Digital tools
- Workflow optimization
Certification
- Good Clinical Practices (2025)
- Situational Leadership (SLII), 2021
- Leader as Coach, 2022
- Diversity & Inclusion Training, 2021
- Conscious Inclusion, 2021
- Cornerstone Leadership Courses (CCK605, CCK609, CCK643)
Accomplishments
- Led monitoring teams across multiple therapeutic areas, improving data currency, trip report turnaround, and overall monitoring quality.
- Developed and implemented risk-mitigation strategies that prevented recurring site issues and strengthened compliance.
- Served as subject matter expert for monitoring operations, delivering training programs and contributing to study/program plans.
- Created and disseminated a bi-monthly monitoring newsletter to elevate communication and best practices across teams.
- Managed clinical projects from initiation through close-out, ensuring adherence to timelines, budgets, and SOPs.
- Strengthened client relationships through effective communication, project presentations, and coordination of account activities.
Therapeutic Experience
- Phase I–III: Cardio-Metabolic
- Diabetes
- Hypertension
- Infectious Disease (HIV)
- Hepatology (Hep C)
- Neurology
- Rheumatoid Arthritis
- Osteoarthritis
- Pain
- Fibromyalgia
- Cognitive Disorders
- Hyperlipidemia
- Alzheimer’s
Timeline
Administrative Assistant
Mount Zion Baptist Church
02.2025 - Current
Partner Line Manager
PAREXEL International
09.2022 - 07.2024
Clinical Monitoring Manager
Advanced Clinical
07.2021 - 09.2022
Manager of Clinical Operations
PRA Health Sciences / Sanofi Pharmaceuticals
04.2017 - 07.2021
Regional Senior Clinical Research Associate
PRA Health Sciences / Sanofi Pharmaceuticals
07.2015 - 04.2017
Regional Sr. Clinical Research Associate
Parexel International
02.2012 - 06.2015
Master of Science - Legal Sciences
Kaplan University
Bachelor of Science - Zoology (Pre-Med)
North Carolina State University