CLINICAL RESEARCH COORDINATOR MENTOR QUALITY ASSURANCE Career Focus Eight years compliance experience Proficient Microsoft office programs Proficient University Michigan systems; MiChart, Careweb, eResearch, Qualtrics, Velos, Wolverine Access Excellent organizational skills Ability learn new databases, software, processes quickly Member UMHS Quality Month Committee Professional Experience August 2011 Current Company Name City State Clinical Research Coordinator Mentor Quality Assurance Project Management Quality Assurance Review Committee Auditor Regulatory, Investigational Drug Service Informed Consents Facilitate Physician chart audit Preparation audit reports Follow-up corrective action plans Data Collection Data Analysis Database Maintenance Protocol compliance Data Management (Sponsored Trials) Provide data management study coordination support faculty members research team conduct clinical trials research Electronic paper Case Report Form completion Organize participate site initiation visits monitor visits Confirm eligibility register patients clinical trials Act liaison Regulatory, Study Team, Sponsor Extract SAEs AEs medical records report IRB Sponsor Prepare deviation reports Research chart maintenance Assist preparation external department audits Development departmental training tools Member eResearch Production Support Team Write, review revise departmental Standard Practice Guidelines Maintain inventory 100 trials February 2010 August 2011 Company Name City State Clinical Subjects Coordinator Regulatory Ensure maintain regulatory compliance 62 oncology clinical trials; Investigator Initiated, Cooperative Group Sponsored Complete initial IRB applications amend applications eResearch Write revise Informed Consent documents Submit reports Serious Adverse Events, Data Safety Monitoring, Scheduled Continuation Renewals Institutional Review board Perform Quality Assurance Regulatory Compliance (QARC) audits Perform audits Investigational Drug Service (IDS) Regulatory preparation Site Initiation Visits Train Interns Preceptors Member eResearch Production Support Team Process submit protocol amendments U M Institutional Review Board Create maintain postings UMClinicalStudies.org ClinicalTrials.gov November 2007 February 2010 Company Name City State Administrative Assistant Senior Healthcare Coordination Quality Assurance Indicator Project (23 sites) Website maintenance Database Management Quarterly reports presentations Proof reading high profile documents Chart Audits chart review Pivot tables Minutes coordination three committees August 2006 November 2007 Company Name City State Administrative Assistant Intermediate Healthcare Website maintenance P-Card Reconciliation five faculty members Calendar management 5 faculty members. Coordination Fellowship Residency programs Expense reports Editing proof reading high profile documents Responsible mass ordering supplies $20,000 annually Preparation creation survey survey mailings Lead poster creation Pediatric Academic Society annual conference Brochure flyer creation Coordination Health Services Research Fellow Seminars Supervision work-study student December 2000 August 2006 Company Name City State Outpatient Clerk III Coordination patient care several departments General clerical duties Staff trainer Education Training Eastern Michigan University City State US Bachelor Business Administration Management Bachelor Business Administration Management Eastern Michigan University, Ypsilanti, MI Certified Clinical Research Professional SoCRA City State US Associates Society Clinical Research The Society Clinical Research Associates, Chalfont, PA Certifications CCRP Clinical Research Coordinator AEs Certified Clinical Research Professional SoCRA Affiliations UMHS Quality Month Committee Presentations Quarterly reports presentations Skills Audits, Quality Assurance, Maintenance, Database, Clerical, Clerk, General Clerical, Outpatient, Clinical Trials, Clinical Research, Audit, Case Report, Case Report Form, Collection, Corrective Action, Corrective Action Plans, Data Analysis, Data Collection, Data Management, Inventory, Liaison, Marketing Analysis, Medical Records, Mentor, Project Management, Training, Administrative Assistant, Healthcare, Database Management, Pivot Tables, Ids, Oncology, Regulatory Compliance, Calendar Management, Ordering, Pediatric, Reconciliation, Access, Databases, Excellent Organizational Skills, Microsoft Office, Ms Office, Organizational Skills