Mackenzie Coleman Email & Phone Number

• Subject Matter Expert in GCP and other applicable regulations for large Site Support Organization
• Mentors CQA Consultants to improve consultant performance and ensure effective outcomes with investigative sites
• Host/support Regulatory Inspections at Investigative Sites
• Assist investigative sites with inspection readiness activities
• Assists with preparation and hosting of external audits
• Perform process/focused audits of investigative sites

• Develops and maintains effective relationships with investigative sites and other SC departments and colleagues
• Monitors and modifies policies and procedures for the investigative sites
• Utilizes quality tools that assess the quality indicators of study operations
• Develops a calendar for monitoring quality indicators for all sites
• Prioritizes quality indicators depending on severity/urgency
• Identifies areas of deficiency in quality and reports those deficiencies to SC… Show more

Nashville, Tennessee

Supports strategic site in audit preparations and hosting. Investigates and responds to Corrective and Preventive Action (CAPA) requests in collaboration with Clinical Operations. Monitor quality indicators/quality check and provides routine reporting to Clinical Quality Assurance and Operational leadership. Identifies areas of quality deficiency ensuring.

Nashville, Tennessee

Assigned to assist Quality Management with the Vendor Management program. Main point of contact for vendor management inquiries from internal colleagues and external companies. Completed vendor assessments and reassessments. Created work instructions and job aids for new vendor management process in SmartSolve eQMS Audit Module.Supported the Global Quality.

Nashville, Tennessee

Dallas/Fort Worth Area

Worked as an Assistant Manager at Stanford Court Apartments in Dallas for two months and the Tallows Apartments in Carrollton for one month. Leased apartments, posted rent and late fees, managed resident move outs and insured statement of deposits were completed in a timely manor. Helped manage the delinquency. Worked as a Property Manager.

Bachelor'S Degree, Property Management Major; Housing Minor

High School

Activities and Societies: National Honor Society, Pre-Med Club Vice President, Civinettes Service Club, Blue Crew Spirit Club