Manage Budgets for 10 Research PhysiciansOversee staff of 25 research assistantsAssist with IRB submissionsFacilitate office procedures

IRB Coordinator

Patient registries provide unique outcome information on pupulations under real-world conditions. As Registry Program Coordinator, I will be contributing to the growth and vaue of the registry by professionally managing the day to day operations.Responsibilities:1. Overall daily management of Registry.2. Interact directly with the physicians, their staff, and act as their 1st point of contact.3. Maintain working relationship with Registry Principle Investigator and internal Coram nursing branches.4. Maintain database of physicians.5. Assist in the identification of patients for inclusion in Registry.6. Assume responsibility for quality and accuracy of data7. Assist in planning, organizing, and development of, and be an active part of the Registry Scientific Review Committee.8. Assist in development of Registry publication planning.9. Development of Registry newsletter and other info for physicians and Coram internal employees.10. Screen and respond to physicians requests for data.11. Perform quality assurance and validation audits to ensure quality control of the management system.12. Maintain documentation on usage, training, operational definitions and changes in procedure.12. Travel to meet physicians and attend conferences.

Largest Privately owned cancer center in Colorado; Responsible for 30 employees covering 12 clinics where research is conducted. Negotiated independent study budgets, leading to a 15% increase in revenue.Improved funding from US Oncology Network (USON) by pointing out the inequity of start up allocations, resulting in a 25% increase.Promoted more team work and improved work environments. Organized a PR committee to arrange sporting events and other activities outside of work, which helped develop personal relationships among staff.

Respiratory and Research Center voted #1 for 11 years running by US News and World Report. Director of Clinical Research Unit Responsible for improving the reputation and profitability of a department whose purpose was to invite research at the institution and be of service and available to the physicians and sponsors.Turned an unprofitable department into a profitable one in less than a year. Doubled the 1st year*s profits in the second year.Facilitated in reorganizing a disjointed department into a functional and cohesive unit by working with staff to solve grievances previously ignored. Fostered a collegial team environment with the members of my staff thru regular communication, recognition, guidance and feedback.Increased the number of studies in the department and doubled the number of physicians utilizing the services of the CRU.Successfully renegotiated unprofitable contracts and budgets and created profitable budget template.Cultivated positive relationships and enhanced customer service to all departments, utilizing frequent communication, listening to physicians needs, and responding to their concerns.Identified the need to collaborate with other departments to share resources and supplies, which resulted in reduced costs and improved patient care.

Clinical Research Organization (CRO) working primarily in the area of Oncology.; Provided leadership for 7 active Clinical trials including working with sponsors to improve protocol development, case report form design and other technical issues.Recruited physicians to participate in studies appropriate for their patient base.Monitored sites to ensure Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).Approved protocol deviations when warranted or granted waivers when appropriate, so as not to interfere with the integrity of the study.Organized and coordinated investigator meetings.Formulated patient enrollment strategies in order to achieve greater efficiency, while meeting budgeting goals and staying within or under budget.Enhanced good working relationships with the pharmaceutical sponsors while supporting the physicians and their staff.Conceived and initiated a nursing committee to review upcoming projects and determine feasibility.

Office of Protocol ResearchActed as operational leader to physicians while serving as liaison between the staff and the pharmaceutical companies to ensure total agreement in all aspects of research. Collaborated with physicians, Clinical Review Committee (CRC), Institutional Review Board (IRB), National Cancer Institute (NCI) and pharmaceutical sponsors to comply with all requirements and MD Anderson guidelines. Balanced IRB and policy matters for the staff and faculty in a manner designed to guide them thru a complicated system and minimize their frustration.Streamlined the hospital database to improve the efficiency and ease of use.Served as Secretary to the Data Monitoring and Safety Committee (DMSC) to insure patient safety. Monitored charts for protocol integrity; sought approval for waivers and facilitated deviations, when necessary. Acted as liaison between Pharmacy and pharmaceutical companies to facilitate drug shipments so that protocols could be activated. Supervised and was responsible for the positive outcome of an NIH audit.

Recognized an opportunity to offer live, professional comedic entertainment to cities where nothing like it existed. Founded Laff Stop, with locations; Managed both locations including all aspects of day to day operations.Worked with managers and agents to negotiate contracts.Developed strategy for advertising and marketing the clubs to increase attendance.Initiated a Club Membership which entitled its members to added benefits.