Chadijah Pratt

About Chadijah Pratt

As an experienced clinical researcher, I have specialized in site start-up and feasibility, utilizing my knowledge of good clinical practices to identify suitable sites for assigned studies during the feasibility stage. My previous experience includes reviewing regulatory documents, informed consent forms, and sponsor-specific materials to drive site activations. I possess strong attention to detail, allowing me to detect errors and identify non-compliant items for mitigation quickly. With previous employment at an IRB organization and CRO, I have honed my multitasking and prioritization skills, delivering quality against tight timelines while meeting the needs of internal and external clients. My enthusiasm for learning new processes and systems keeps me motivated and ready for any challenge.

Experience

1. Site Start-up Specialist

   ProPharma

   Sep 2023 — Present

   Update knowledge on related regulatory requirements, ensuring adherence and compliance with local regulations and internal procedures.•Execute all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines.•Prepare country level Informed Consent Form (ICF) and obtain ethics committee and local regulatory approval.•Prepare ongoing submissions, amendments, and periodic notifications required by ethics committees and regulatory authorities.•Maintain and analyze study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.•Partner with other study team members to provide guidance on regulatory and ethical requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions / activations.•Support drug label preparation and approval (as local label representative) for studies in collaboration with local regulatory / quality department as required.•In collaboration with Clinical Site Manager, identify and track new investigator sites performing feasibility, as applicable, and develop and support effective patient recruitment and retention practices, as required.•Responsible for study budget and contracts negotiation in collaboration with contracts manager / associate, as required and ensure compliance with Fair Market Value (FMV) in the region.

Education

• North Carolina Agricultural and Technical State University

  Bachelor's degree, Sports Science & Fitness Management / Business Administration

  2011 — 2016