Skilled in site activation tracking and document readiness reviews, preparation and QC of regulatory documentation for activation, and serving as a communication liaison between sponsors, CROs, and site teams.
Expertise in the collection, QC, and tracking of essential regulatory documents, and the preparation, submission, and management of IRB submissions and correspondence.
Ensures adherence to industry standards, OSHA guidelines, and environmentally sustainable practices through regulatory compliance assessments, internal process audits, inspection readiness checks, SOP review and development, site staff training, Trial Master File (TMF) and Investigator Site File (ISF) quality control.
We don’t just start studies, we start them right, with operational excellence and regulatory integrity.
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