BEVERLY MINGLEE

• Compile and analyze study data using various electronic data capture software.
• Ensure clinical trials remain in compliance with all IRB and FDA regulations, along with any other departmental institutional, and federal requirements.
• Learned and adapted quickly to new technology and software applications.

• Sustained direct communication with corporate staff and regional mentors for shared resources in budgeting, staffing, software support, completing action plans, and creating PowerPoint presentations. Managed Physical, Occupational and Speech therapy departments and reviewed documentation.
• Provided daily reports via email, uploaded to MS Outlook 365 for sharing spreadsheets, Excel, PDF, zip-files, and monitoring productivity in Rehab Optima and Point Click Care.
• Managed Physical, Occupational and Speech therapy departments and reviewed documentation.
• Coordinated own work schedule with flexibility to arrange priorities daily.
• Responsible for responding to Additional Development Request (ADR) denial letters from Centers for Medicare and Medicaid Services (CMS) and wrote appeal letters with the most recoupment in reimbursement claims and providing feedback from monthly audits for improvements in documentation.
• Results-oriented developing positive and cohesive rehab departments by scheduling visits to facilities every month to orient and furnish updates from Centers for Medicare and Medicaid Services (CMS), attending stand-up meetings in skilled care facilities and preparing staff for survey readiness.
• Developed and mentored teams overseeing 16 buildings in Southern California.
• All facilities passed the Department of Health Services (DHS) annual survey each year.
• Assisted in opening and training selected employees for 24 start-up departments in Southern California.

• Leadership, managerial, and application of principles in supervision.
• Decision making and conflict resolution skills for the hospital and two satellite hospitals.
• Implemented resource utilization strategies of personnel employed and budgeting.
• Evaluated and maintained regulatory requirements, Joint Commission regulations and professional standards.
• Established and enforced performance evaluations/expectations for patient care.
• Collaborated with management new strategies to initiate with internal staff.
• Increased communication and conflict resolution, and promoted team building.
• Held position of Chief Commanding Officer of the HAZMAT unit for disaster preparedness with the country of Israel.

• Management, leadership, problem-solving abilities, and effective communication skills.
• Supplied clinical and administrative resources to nursing personnel to facilitate the delivery of safe and effective patient care.
• Problem solving in any area of the hospital that directly affects patient care and nursing budget.
• Two years of EPIC Electronic Health Records (EHR) for training staff and three major Northwestern hospitals in IL.
• Activated Emergency Response for waterline flooding of the hospital. Notifying appropriate authorities on the night shift which enabled the hospital out-patient surgical suite to open the next morning.

Nurse Coordinator:

• Retrieved and submitted clinical trial reports for a specialized lung study to an outside data source.
• Performed QA of budget, CRA trip reports, entered data, and escalated results to CTM.
• Systemized and developed report tracking, also created CTMS critical document files according to GCP and FDA guidelines.

Nurse Coordinator:

• Prepared educational material and training, staffing the call center in major pharmaceutical phase III orthopedic study for optimal dosing.
• In direct communication with principal investigators and staff.
• Tracked patient enrollment, received and submitted lab values, reporter serious adverse events, adhered to protocol, data integrity, and regulatory compliance.

Central Safety Nurse:

• Medical safety surveillance for innovative erectile dysfunction study drugs.
• Web-based pilot study done entirely on the internet with one-day data lock.
• Direct communication with sponsors, maintained protocol timelines, and budgeting.
• Monitored for serious adverse events, practiced GCP, FDA, and ICH regulatory guidelines.
• Pioneered the first web based clinical trial pilot study for the competitor of Viagra known as Cialis.

Nurse Coordinator:

• Facilitated start-up of RN staffed call center in three year pharmaceutical phase III compassionate-use study drug for efficacy and safety.
• Upheld communication with principal investigators (PI), Internal Review Board (IRB), and hospital staff.
• Strict adherence to protocol, GCP, ICH, and FDA guidelines.
• Applied solid nursing knowledge for resolutions to issues and questions.
• Sent, retrieved, and maintained critical documents timely.
• Arranged and initiated authorization of study drugs across the United States and Canada.
• Notified sponsor of inconsistencies in protocol, offered solutions and aided with renegotiations toward a new budget and timeline expectations.
• Persistent to review clinical trial protocols and identified an error in sequencing and offered a solution saving the company time and budget costs.
• Resourceful in providing clinical trial compassionate-use study drugs to the U.S. and internationally for three years.

• Provided professional nursing care for acute med/surg., pediatrics, and oncology patients.
• Maintenance and removal of epidurals for pain control.

• Responsible for recalculating and administering chemotherapy.
• Administered medications, TNA, blood components, and managed PCA's.
• Provided maintenance and removal of subclavian central lines.