Salt Lake City, UT
Projects and Grants Manager
May 2011 to Present
• Conduct preliminary reviews of research submissions and prepare for submission to full IRB review or expedited review by IRB chairperson. Use judgment to determine if projects are compliant with federal research regulations and Intermountain policies. Use judgment to determine appropriate review processes. Facilitate investigators in the preparation and completion of submissions.
• Track ongoing approval of studies and IRB activities.
• Coordinates with Office of Research IRB Coordinator to ensure accurateness and completeness of submitted packages. Communicates with Office of Research IRB Coordinator decisions in a timely and efficient manner and follows-up on committee actions items.
• Communicate effectively with Office of Research IRB Coordinators.
• Communicate effectively with Principal Investigators and study teams. Inform researchers of IRB decisions. Provide education and direction regarding the fundamentals of human subjects research, Intermountain IRB/Research policies, procedures, and guidelines, and federal and state regulations.
• Prepare for successful audits, management with the development and execution of institutional policies and procedures to ensure Intermountain Healthcare compliance with Federal, State and local laws and regulations related to research.
October 2007 to May 2011
• Oversees all aspects of Clinical Research Operations to facilitate completion of clinical projects conducted at the site.
• Supervises clinical projects conducted at site while serving as a resource for clinic staff.
• Coordinates staffing schedule and assignments.
• Interacts/communicates with Investigator, study sponsor and regulatory monitors regarding study related issues.
• Updates Project Manager on status of study progress.
• Ensures site compliance of study requirements, SCIREX policies and FDA regulations.
• Provides resource planning for equipment, facilities and organization of space.
• Supervises lab operation to maintain safe working environment and compliance with OSHA standards.
• Completes staff performance reviews and counseling.
• Reviews, and assists in the development of, draft protocols and proposals.
• Assists in developing enrollment timelines for each study and ensures that all enrollment goals are met.
• Interviews, hires and assists with training of new staff.
• Assists with and/or assumes Clinical Research Coordinator responsibilities when necessary.
• Ensures adherence to budget allocated for the site. Assists with development of budget and monitors site expenses.
Director of Clinical Trials
July 1998 to August 2006
Formerly) Intermountain Hematology/Oncology Associates, P.C.
Salt Lake City, Utah.
Responsible for the daily operations of all industry sponsored clinical trials at all Utah Cancer Specialists locations. Provides supervision and training to all clinical research associates, Regulatory Coordinators as well as researching current opportunities for expansion of the pharmaceutical clinical trials program. Responsible for compliance to FDA and GCP guidelines with regulatory NDA submissions, budgets, contracts, investigational drug/device storage and tracking, sponsor contact, ISO9000 and FDA inspections. Responsible for evaluating and submitting complex data records regarding serious adverse events.. Also served as a liaison to Investigators, Contract Research Organizations (CRO) and Pharmaceutical Companies.
Regional Head Certified Clinical Research Associate
October 1995 to June 1998
10/95 - 6/98 Regional Head Certified Clinical Research Associate
Southwest Oncology Group Clinical Trials, Huntsman Cancer Institute;
University of Utah, Salt Lake City, Utah.
Responsible for the coordination, supervision and training of 11 local and regional Clinical Research Associates and Registered Nurses for Southwest Oncology Group trials. Organize and maintain quality assurance with eligibility and protocol compliance for more than 70 open trials. Responsible for meticulous reviewing of data records with site visit teams, NCI, FDA and other appropriate agents. Review investigational drug logs and inventories insuring that appropriate documentation is accurately maintained and Federal guidelines are being met. Responsible for maintaining membership and certification with SOCRA. Liaison between University of Utah investigators, affiliate investigators, clinical research associates and Southwest Oncology Group Operations and Statistical offices.
Clinical Research Associate
March 1995 to October 1995
Salt Lake City, Utah.
Evaluate patients for eligibility and randomize them for clinical trials. Responsible for collecting and submitting data for patients currently on studies, and following patients long term who previously participated in studies. Obtain and submit x-rays, operative reports or other specialized reports as needed for protocol purposes. Responsible for reporting adverse drug reactions to appropriate persons. Liaison to University of Utah investigators and support staff.
Clinical Research Coordinator
March 1993 to March 1995
Salt Lake City, Utah.
Coordinated several protocols for familial cancer studies. Responsibilities included patient recruitment, monitoring study compliance, assisting principal investigators with abstracting, collating and analyzing data from data collected via paper and computer databases.
Bachelors of Science in Behavioral Science and Health