Billy Viellot

Set up and maintained site-level TMF/eTMF, coordinating document collection and uploading into SharePoint/eTMF while ensuring completeness and quality control. Coordinated EC submission dossiers, site start-up preparation, and managed EC fee applications and tracking.

Supported Essential Document Leads and Managers in optimizing EDM processes, applying creative solutions to complex site-ready situations. Monitored and tracked compliance of study essential documents, ensuring the integrity of clinical trial documents.

Contacted internal and external customers regarding delivery methods, resolving concerns and conflicts to provide customer solutions. Worked independently to make difficult decisions and handled verbal and written contacts with third-party delivery companies.

Evaluated subsidized childcare needs for clients on Temporary Assistance for Needy Families and reviewed applicant eligibility for childcare provider positions. Led multi-site in-person presentations for childcare providers, coaching them through the application process and explaining program policies.

Managed over 30 cases for families and vulnerable children, assessing needs during home visits and connecting clients with over 100 resource organizations. Communicated with the Department of Human Services regarding client progress and documented assessments and resource allocation.

Supervised 10-12 adult employees with mental health disabilities, implementing and monitoring their progress towards individual goals. Documented employee payroll and production records, while providing individualized attention to promote physical, mental, and psychosocial well-being.

Supported children ages 5-14 with Autism Spectrum Disorder, providing behavioral interventions and therapeutic aid to foster social skills and independence. Assisted in developing peer networks and facilitating clients as active community members.

Received medical documents from various departments and scanned patient identification and medical records into the electronic health system. Organized records within the database and managed billing statements and mail distribution.

Studied Human Services at Gwynedd Mercy University. Gained foundational knowledge and skills relevant to supporting individuals and communities.

Completed coursework in Clinical Research, focusing on the organization and functions within a Trial Master File (TMF). Reviewed regulatory climates, essential documentation practices, and quality control of TMFs.

Learned about key regulatory documents used in clinical research, emphasizing the importance of Institutional Review Board/Independent Ethics Committee. Studied their collaboration with investigators and sponsors for successful clinical trial execution.