Megan McCain, Senior Study Manager
Megan McCain serves as a Senior Study Manager, bringing nearly a decade of hands-on clinical research experience across Phase I–IV trials. Known for her operational leadership and regulatory precision, Megan plays a key role in driving clinical studies from initial planning through successful execution.
Her background includes national site start-up operations, cross-functional team training, regulatory oversight, and full-cycle trial management. Megan has supported multi-site studies across the United States, ensuring compliance with Good Clinical Practice (GCP), sponsor expectations, and FDA standards.
With strong expertise in trial logistics, patient coordination, and quality assurance, Megan contributes to the seamless execution of complex clinical programs while maintaining a sharp focus on data integrity and patient safety.
Area of Expertise
- Nearly 10 years of progressive clinical research experience across regional and national research networks
- Senior Study Manager overseeing full lifecycle trial execution, including scope development, budgeting, scheduling, and regulatory compliance
- Senior Traveling Clinical Research Coordinator supporting site activation across the United States, including equipment setup, staff training, lab coordination, and sponsor communication
- Clinical Research Coordinator I–II with direct patient-facing responsibilities including vitals, ECGs, spirometry, laboratory collection, adverse event documentation, and regulatory binder maintenance
- Consistently maintained 100% compliance ratings during third-party audits
Professional Experience:
- Nearly 10 years of progressive clinical research experience across regional and national research networks
- Senior Study Manager overseeing full lifecycle trial execution, including scope development, budgeting, scheduling, and regulatory compliance
- Senior Traveling Clinical Research Coordinator supporting site activation across the United States, including equipment setup, staff training, lab coordination, and sponsor communication
- Clinical Research Coordinator I–II with direct patient-facing responsibilities including vitals, ECGs, spirometry, laboratory collection, adverse event documentation, and regulatory binder maintenance
- Consistently maintained 100% compliance ratings during third-party audits
Education
- Clinical Trial Management (Phases I–IV)
- Study Planning, Budgeting & Timeline Oversight
- Regulatory Submissions & Audit Readiness
- Adverse Event Reporting & Safety Monitoring
- Data Collection, Validation & Interpretation
- Medication Accountability & Drug Dispensing
- Clinical Trial Budget Management
- Risk Assessment & Quality Assurance
- Site Start-Up & Equipment Calibration
- Phlebotomy & Clinical Procedures
- Community Outreach & Participant Recruitment
- Scientific Documentation & Reporting
Contributions to Research
- Leads study start-up activities, including regulatory submissions and operational readiness
- Coordinates and trains research teams across multiple clinical sites
- Oversees participant recruitment, tracking, and retention strategies
- Ensures accurate source documentation and timely data reporting
- Manages adverse event reporting and medication accountability
- Maintains sponsor communication and cross-department collaboration
- Supports continuous quality improvement initiatives and audit preparation
- Clinical Research Focus Areas
- Multi-Site Clinical Trial Operations
- Phase I–IV Industry-Sponsored Studies
- Regulatory Compliance & Audit Preparedness
- Site Activation & Staff Training
- Patient-Focused Clinical Coordination
- Drug Accountability & Safety Monitoring
- Operational Risk Management
- Data Quality & Study Integrity
- Licenses & Certifications
- Phlebotomy License
IATA Certified - Good Clinical Practice (GCP) Certified
CPR/AED Certified