Quality Assurance Manager
Resume:
Crystal Cunningham
Alpharetta, GA
******@*******.***
SUMMARY
Over ten years experience in clinical research administration, documentation analysis and coordinating clinical trails. Proven results in team building, project management, clinical trial design and development/deployment of innovative research-driven products. Extensive knowledge in: diabetes, high cholesterol, osteoarthritis, schizophrenia, bipolar, insomnia, depression, dementia, alcohol dependency, hypoactive sexual dysfunction disorder, and infertility.
EDUCATION AND CERTIFICATIONS
2006 Georgia State University Atlanta, GA
Bachelor of Science, Psychology
2003 Georgia Perimeter College Atlanta, GA
Associate of Science, Early Childhood Education
2009 IATA and BLS Certified Atlanta, GA
PROFESSIONAL EXPERIENCE
06/2011 current Emory University Office for Clinical Research Atlanta, GA
Clinical Research Finance Manager
• Coordinates and oversees the financial management of National Institute of Health or industry sponsored trials.
• Reviews study protocols for financial and resource feasibility.
• Develops budget and writes budget justification.
• Adheres to Cost Accounting Standards and justifies exceptions for approval.
• Revises budgets, negotiates, prepares best and final offer, and obtains final University approval.
• Monitor budget and accomplishes study goals within budget.
• Provides direction in auditing and monitoring activities.
06/2009- 06/2011 Reproductive Biology Associates Atlanta, GA
Sr. Clinical Research Coordinator
• Complete all phone screenings, consent process, enrolled and randomized qualified patients.
• Complete all regulatory, source, and eCRF for Pharmaceutical Company.
• Coordinate all infertility diagnostic tests and treatment plans for the study.
• Schedule and coordinate IVF/ICSI cycles, including follow-up procedures.
• Perform patient education on daily injections, and study diary to explain and define medical treatments and procedures.
• Develop and maintained a partnership with the patient and family to facilitate and navigate through subsequent treatment and follow-up i.e. outcome of patients delivery.
• Monitors the handling, storage and disposal of hazardous substances.
12/07-6/2009 Comprehensive Neuroscience Atlanta, GA
Lead Clinical Research Coordinator
• Complete all study documentation forms and other clinical trial specific documents, including
detailed source documentation [case report form (CRF) or electronic case report form (eCRF)] in a timely manner.
• Develop or assist in advertising, where applicable, coordinate ad placement with
site staff, with complete and accurate advertising schedules and maintained media cost to insure
that recruitment costs are within the budgets provided by sponsor companies.
• Build and maintain relationships with referral sources including but not limited to local case
management agencies, area hospitals, homeless shelters, and area physicians.
• Serve as a liaison between clinical trial candidates, case workers, family members, and CNS to
ensure continuity of care.
• Identify appropriate candidates for study participation and review protocol specific criteria to
determine eligibility.
• Meet target number of monthly consented clients.
• Oversees quality assurance of research performed by others
11/05-12/07 Laureate Clinical Research Group Atlanta, GA
Clinical Research Data Intake Coordinator
• Recruit participants for trials by reviewing charts, phone screenings, contacting patients arranged by physicians, and planning and arranging of advertising campaigns fir studies to be undertaken.
• Scheduling of all study-related screening appointments and procedures.
• Identifying problems and implementing solutions to ensure proper management and conduct of clinical trail screening.
• Cooperate with Sponsors’ clinical monitors in a timely resolution of any and all data clarification discrepancies.
• Attend all Sponsors’ mandatory trail start- up meetings.
• Develop a thorough knowledge of study protocol.
08/99 – 11/05 Kaiser Permanente Alpharetta, GA
Certified Lab Technician
• Supervised front desk operations and ensured strict adherence to departmental policies and procedures
• Maintained strict adherence to HIPAA for all activities including all implementations and enhancements to Hospital Information Systems
• Documented requirements for EHS
• Processed new member applications in Epicare/Hyperspace
• Entered and tracked lab results in designated systems and produced reports as required
• Utilized systems to validate member identification and eligibility
TECHNICAL EXPERIENCE
• Microsoft Office Suite Microsoft Project Electronic Medical Records
• Lotus Notes Cerner RDC-Oracle
• Epic/Hyperspace Health Connect People Soft
• Cadence Study Manager Inform
• Medidata/Rave SPSS/SASS
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