Category: HEALTHCARE

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