Lin Wingate Email & Phone Number

Annapolis, Maryland, United States

Executed clinical study site management/monitoring activities in strict compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.Conducted remote and on-site monitoring and oversight activities, utilizing various tools to ensure complete, accurate, and unbiased data generation at sites.Worked collaboratively with internal stakeholders and external partners, including GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, vendors, and regulatory authorities.Travel to multiple sites 2-5 days per week with a utilization of 65% or more at atleast 3 sites.

Manage participant recruitment efforts in order to meet site enrollment goals, increase participant diversity, and to aid sponsors in meeting enrollment deadlinesWork closely with principal investigator and sub investigators to monitor patient safety during the observational period of the trialManage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for ensuring the ongoing training needs of site staff members are met.Ensured the protection of subjects' rights, safety, and well-being.

Routinely tested products to align temperature, specifications and reagent levels with best practices and quality standards.Educated employees on specific QA standards and confirmed maintenance of standards.Developed monthly, end-of-quarter and other statistical reports, including analysis for leadership team and for quality improvement program outcomes studies.Inspected, verified and documented quantifiable characteristics of finished goods, comparing against customer specifications and company quality standards to achieve acceptable product.Tested and operated instruments to confirm correct calibration while scheduling routine, preventive and reparative maintenance to maintain production workflows and achieve production output benchmarks.

Planned and monitored curriculum and program activities and liaised with teachers to create fun and engaging learning experiences.Operated under licensing guidelines to protect health, safety and well-being of children.Resolved conflicts and administered corrective action to foster positive experience for children, staff, and parents.

Provided regular updates to team leadership on quality metrics, communicating consistency problems or production deficiencies with quality and production leadership.Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.Inspected, verified and documented quantifiable characteristics of finished goods, comparing against customer specifications and company quality standards to achieve acceptable product.Educated employees on specific QA standards and confirmed maintenance of standards.