Donna T

Clinical Research - 20 Years of Experience - Near 43003


Registered Nurse


Ashley, OH

Education Level:


Will Relocate:



Summary of Qualifications and Skills Graduate prepared nurse with a Clinical Specialist in Oncology with a minor in HIV Disease. Broad pharmaceutical experience, starting as a Research Coordinator in academia, an in-house Clinical Research Associate (CRA) in Biotech, Associate Director in Global Operations in Clinical Pharmacology with Aventis Pharmaceuticals, and as a home-based CRA Responsibly managed multiple projects and therapeutic areas in accordance with Good Clinical Practices (GCPs)/ICH, SOPs, monitoring plans, company timelines and company guidelines. According, accountable for the data quality and maintaining quality communication with clinical investigators, site management and all other shareholders while ensuring patient safety. Experienced completing site management activities such as, Pre-Study Visits, Site Visits, Interim Monitoring Visits, and Close-out Visits. Skilled trainer ensuring understanding of the protocol and required procedures and documentation by the Investigator's site. Keeps up active communication and documentation with the sites as in follow-up letters to investigator following a site visit. Familiar with several remote data entry software systems. Partners and demonstrates excellent communicate with sites, manager, project team and other functional areas to ensure recruitment goals are met. Meets study plan metrics. Submits monitoring visit reports, etc. for all monitoring visits conducted and follows up on follow-up items each visit. Reports consistently submitted within the allotted time frame. Takes decisive action based on business strategy. Excellent ability to cope with stressful situations, and multiple priorities fluidly. Flexible leader and expert strategist who delivers' unique change-management initiatives, motivating staff, increasing production. Outstanding ability to identify analyze and solve problems there by increasing outputs. A champion for change.


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