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• Identifies, reports… Show more • 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• Identifies, reports and prioritize quality indicators for investigative sites• Works cross functionally to ensure optimal efficiency in quality indicator reporting and escalation• Reviews investigative site CAPAs and performs Effectiveness Checks as required Show less

•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 •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 Directors and other appropriate colleagues•Assists the investigative sites in development and modification of clinical research SOPs and Work Instructions•Assists with preparation and hosting of external audits•Assists research staff in maintaining FDA compliance•Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership•Develops time line to ensure timely and appropriate follow-up in areas of deficiency•Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate•Assists sites with responses to external audits and CAPA development•Maintains records of audits and reports•Communicates with monitors and auditors of clinical trials, as needed•Educates staff in quality improvement methods and industry trends Show less

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 escalation to operational leadership. Assists in the development and modification of departmental work instructions. Educate research staff… Show more 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 escalation to operational leadership. Assists in the development and modification of departmental work instructions. Educate research staff in quality improvement methods. Assists research staff in maintaining federal regulation compliance. Host and support site in regulatory inspections. Show less

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 and Education department.

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 September-December at Villas at Waterchase Apartments in Lewisville. Effectively managed the staff with strong leadership. Managed renewals and other… Show more 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 September-December at Villas at Waterchase Apartments in Lewisville. Effectively managed the staff with strong leadership. Managed renewals and other resident retention events. Helped improve the 60 day trend from 88% to 94% in two months.Currently working as the Assistant Property Manager at The Tallows Apartments in Carrollton. Show less

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