Kathleen Eagle Email & Phone Number

On assignment for Pfizer - January 2011 to January 2012On assignment for Roche - January 2007 - January 2011• Provided line management for up to 17 CRAs • Ensured CRAs met commitments by monitoring regional project milestones and performance metrics; implemented action plans for the successful completion of U.S. clinical trials • Worked on process improvement initiatives• Forecasted regional resource requirements to ensure all projects monitored by the U.S. Regional Monitoring Network were adequately staffed • Interviewed and hired new CRAs to maintain adequate staff to meet project commitments • Performed assessment visits with CRAs to evaluate quality of monitoring and site management; provided ongoing training and coaching• Ensured compliance of client SOPs in conjunction with the Field Compliance and Training Manager• Conducted performance management: set expectations and provided performance coaching and development of action steps, conducted performance appraisals

Sr. Manager of ClinicalOperations - Dec 2005 to Jan 2007• Responsible for the line management of 8 CRAs and 2 CRA Managers • Additional responsibilities listed below under Manager of Clinical Operations Manager of Clinical Operations - Dec 2002 to Nov 2005• Ensured staff fulfilled their responsibilities in accordance with PRA’s policies, procedures, SOPs, ICH-GCPs, and country specific regulatory requirements• Developed CRAs to ensure optimal performance and retention of high quality employees• Conducted bi-annual performance reviews• Conducted co-monitoring assessment visits with CRAs to ensure quality monitoring• Managed the utilization of individual CRAs• Ensured clinical staff received appropriate functional area training• Aligned with 5 projects; helped to ensure the effective execution of the monitoring portion of the study • Assisted with providing training for PRA's CRA Foundations Training program• Assisted with process improvement initiatives• Managed operational budget within respective budget guidelines• Provided input to central proposals for project bids to ensure all projects were managed within contractually agreed upon schedules and budgets• Participated in interview process when recruiting new staff members• Participated with preparing client bids and participated in client presentations and bid defense meetings

• Functioned as lead Clinical Research Associate for multiple oncology clinical drug trials• Provided written and oral communications to sponsors regarding study progress and conduct• Oversaw data management, statistical and programming deadlines for the trials• Communicated with regional CRAs regarding study related issues • Reviewed and tracked trip reports• Assisted in study contract development • Negotiated bid proposals for CROs and trained new CRAsClinical Research Associate, February 1996 to November 1997• Qualified, initiated, monitored, and closed out sites• Ensured all activities were completed in accordance with study protocol, investigator agreement, FDA regulations and GCPs• Reviewed patient data on the case report forms and compared to source documents for accuracy• Resolved queries and reviewed drug accountability at investigator sites • Functioned as a liaison between the sponsor and the investigators and trained new CRAs

• Acquired extensive experience with a contract research organization assisting diverse pharmaceutical manufacturers with clinical trial management and support• Qualified, initiated, monitored, and closed out sites• Ensured all activities were completed in accordance with study protocol, investigator agreement, FDA regulations and GCPs• Designed case report forms and participated in investigator site selection

Bachelor Of Science - Bs, Biology, General

Activities and Societies: Omega Psi

Master Of Science - Ms, Biology