Marie E. Email & Phone Number

Morrisville, NC, US

-Perform monitoring and site management activities as per study management plans onsite and remotely.-Perform Site Qualification, Site Initiation, Interim Monitoring, Site Management and Close-Out Visits.-Ensure ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures.

Durham, North Carolina, US

-Conduct SSVs, SIVs, IMVs and COVs.-Assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. -Review regulatory documents as required and prepare site visit reports. -Responsible for multiple projects; work both independently and in a team environment.-Review CRFs, Informed Consent Forms and provide site re-training as needed.

• Ensure data quality and FDA compliance for Pharma clients (pharmaceuticals, biomedical device) from inception to completion
• Monitor the conduct and progress of assigned Pharma projects according to company standard operating procedures, Governmental Regulatory bodies, guidelines and local laws
• Monitor entire project disciplines, including the review of incident report forms and initial documentation to ensure adherence to project protocol, consistency and data integrity
• Maintain strict confidentiality, work closely with data management and representatives from pharmaceutical companies to resolve discrepancies, report deviations, escalate compliance infractions and route to the.

• Ensured Pharma clients adhered to Good Practices Principles, SOPs, and project protocols
• Reviewed regulatory documents as required and prepared project monitoring progress reports
• Participated in the project development and start-up process including standardized protocols, designing and reviewing regulatory governing body codes
• Identified areas of project non-compliance, trained associates in company standard operating procedures, guidelines and regulatory requirements to avoid reoccurrences
• Performed file audits and project closeouts according to company guidelines and SOP’s

Master Of Business Administration (Mba), Finance, General

Bachelor Of Arts (Ba), Business Administration And Management, General