Katie Climo

•Planning and execution of Phase II/III international clinical trials from initial study design through regulatory submission. Overall responsibility for study management in terms of time, resources and budget to ensure that program objectives are met in a timely and cost efficient manner. •Organize, coordinate and manage cross-functional project teams including clinical operations, data management, biostatistics, medical writing, clinical QA and external partners to ensure quality, on-time deliverables

•Responsible for performing and coordinating all aspects of the clinical trials monitoring process to assure adherence to GCPs, and global SOPs to assess the safety and efficacy of investigational products. •Conducted investigative site visits to determine protocol and regulatory compliance, and prepared required documentation. •Represented the pharmaceutical research company in the global medical research community and developed collaborative relationships with investigative sites

•Managed all aspects of the start up and ongoing conduct of international multi-center clinical trials. Acted as liaison to CROs, clinical investigators and study site personnel to ensure compliance with study protocol and overall scientific objectives. Provided specific tracking of study status, timelines, budgets and clinical trial material needs. •Participated in the preparation and review of clinical protocols, design of CRFs and database specifications.

•Managed investigative sites in Phase I through III multi-center clinical trials for international Contract Research Organization. •Performed all types of site monitoring visits and coordinated all aspects of the clinical monitoring process in accordance with GCPs, ICH guidelines and global SOPs to assess the safety and efficacy of investigational products. Conducted site visits to determine protocol and regulatory compliance and to ensure the quality and integrity of the data collected.

•Performed clinical duties in Emergency Department of level 1 trauma center with patient visits greater than 72,000 per year. •Triage Nurse responsibilities included assessing and evaluating patients to determine appropriate level of care needed. •MICN (Mobile Intensive Care Nurse) responsibilities included communicating with paramedics via radio to manage patients’ pre-hospital care and documenting information and outcomes in computer database.