Sharell Risher

Accountable for site activation through close-out, ensuring regulatory compliance and data integrity across country-level sites; managed TMF quality, ICF translations/negotiations, and resolved site activation risks to meet timelines.

Conducted site selection, initiation, monitoring and close-out visits under FSP model, ensured protocol and GCP compliance, and prepared regulatory submission materials including TMF and site essential documents.

Led regulatory and site start-up activities including IRB continuing reviews, modifications, and feasibility assessments; educated staff and sponsors and served as primary liaison for safety and regulatory reporting.

Served as lead clinical coordinator overseeing study start-up, IRB amendments, risk assessments and team mentoring; directed operational feasibility and project management from inception to completion.

Piloted data entry processes and site activation deliverables, managed IRB submissions and regulatory documents, and improved departmental performance via implementation of electronic regulatory signatures.

Coordinated patient scheduling, eligibility assessments and accurate data collection to support clinical trial audits and ensure protocol compliance during study conduct.

Bachelor of Arts in Communication Studies with a concentration in Healthcare focused on communication practices within healthcare settings.