Hope Dunn Email & Phone Number

Boston, Ma, Us

Phase I and II Oncology studies

• Experience in Phase II and Phase III clinical trials, including oncology, COVID-19, hypertension, and macular degeneration • Work closely with and support a global project team, including internal and external customers and suppliers through all phases of a study • Administrate consistent support of site level document collection through partnership with Clinical Research Associate (CRA) and/or directly from site. Identified, managed, escalated where appropriate, and resolved site issues effectively• Assist with protocol amendment processing, including site notification, supply shipment, budget and Informed Consent Form updates and review, and IRB/IEC submissions• Conduct document review/support with document query resolution of assigned content within Trial Master File (TMF) and Clinical Trial Management System (CTMS) and submit documents/files directly within TMF• Experience with multiple TMF systems, including Trial Interactive and Veeva Vault• Maintain study servers and portals while tracking documents and study status in tracking systems• Facilitate budget negotiations, fee tracking, and data entry• Support study team with functionality and use of TMF/CTMS in accordance with study-specificTMF plan, Clinipace Standard Operating Procedures (SOPs) and study-specific processes• Contributor in internal and external meetings to communicate functional area study status and toprovide associated reports to the study team• Supports regulatory inspections and/or audits as required • Interfaces with vendors as required • Conducts designated final site level TMF review and assists with final document collection at Close Out Visit• Assist with the training and onboarding of new team members to the Site Management team

Portsmouth, New Hampshire, United States

Dover, New Hampshire

Durham, Nh

Master Of Science - Ms, Foods, Nutrition, And Related Services

Bachelor Of Science - Bs, Nutritional Sciences