Economically Disadvantaged Woman Owned Small Business providing top quality technical, scientific and managerial support to government, private and clinical research companies.

Manage clinical research trials

Regionally-basedIn a matrix environment, managed, led and motivated the cross functional project team, facilitated the team's ability to fulfill their responsibilities in accordance with project contracts, contract amendments and Omnicare Clinical Research (OCR) policies, procedures and SOPs. Extensive writing experience:Developed all written, project-related materials for assigned oncology and dermatology studies, including Investigator's Brochures, regulatory documents and study newslettersCreated technical and scientific documents and presentations by interpreting and converting raw study data into written, legible form for use by project management and other departmentsDeveloped and authored Clinical Monitoring Plans Risk Management Plans, Data Management Plans, Communication Plans and other project plans for assigned studiesDeveloped and presented Power Point presentations at investigator meetings Constructed informational slideshows and project materials summarizing the protocol and clinical procedures, to be presented by the study team to study investigators and other site personnel Created paper and electronic Case Report Forms (CRF) and Case Report Form Completion Guidelines, providing specific explanations of how study data should be collectedProofread and edited all study materials, monitoring reports, regulatory documents and project plans for final approval Additional managerial responsibilities: managed daily operations of multiple projects; supervised and ensured successful design and implementation of project plans; coordinated with corporate finance to determine appropriate revenue forecasting, budgets, contracts and scope changes

Regionally-basedWrote scientific/technical documents from raw project materialComposed monitoring guidelines for project team prior to study initiation; obtained sponsor's approval, and conducted CRA training to these guidelinesAuthored all types of comprehensive monitoring reportsCreated detailed study tools for project team useDesigned Power Point presentations and study-related materials for site training and CRA training purposesCreated guidelines and maintained updates, as needed, throughout the conduct of the studyDeveloped company checklist of responsibilities for Lead CRAs, including time management guidelinesRedesigned clinical tracking reports and contact listsCreated company's Investigator Database including a ratings system for site selection and recruitmentAdditional responsibilities: trained and managed junior associates; facilitated internal and external team meetings; reviewed and maintained regulatory files; acted as main study contact in sponsor audits and effectively worked with other internal departments to assure project success.

Concurrently managed all aspects of clinical operations for the administration of four global HIV/AIDS trials. Extensive writing experience:Wrote original protocol amendments, Study Manuals, Investigator Brochures, Monitoring Plans and Status Reports Interpreted raw study data to create Clinical Statistical Reports Developed Case Report FormsConstructed, edited and managed regulatory documents Additional responsibilities: forecasted study budgets; updated site contracts; authorized release of study drug; ensured team members acted in accordance with SOPs, Good Clinical Practice and FDA regulations.

Regionally-basedAuthored comprehensive visit reports and status reports for all site visitsCreated functional study tools for study teamAssisted in writing of monitoring plans, weekly newsletters and other clinical documentsRedesigned outdated study materials to benefit project teamConducted monitoring visits, managed sites, identified potential investigators and ensured compliance with all protocol, regulatory, GCP and ICH guidelines.

Thesis- based internship for completion of Masters ProgramAssisted with state-mandated project to screen and track elementary school students for various health risks.Collected original data points and created a database to help identify children at risk for obesity Developed detailed presentation for parents, based on collected results explaining risks of childhood obesity

Designed and constructed study reference manuals for trial protocolsConstructed final drafts of Clinical Statistical ReportsReviewed and audited regulatory documents for medical integrity and data consistency with FDA regulations and GCP and IRB guidelinesPerformed conventional CRA duties as a liaison between sponsor companies and participating investigational sites.