Qualifications Summary

Experienced in on-site monitoring and site management of Phase I and 2A pharmaceutical and methodology studies in multiple therapeutic areas. Proficient in coordination of pharmaceutical, endovascular medical device and contrast agent clinical studies. Experienced with Core Lab services in Radiology. Knowledgeable of interventional radiology procedures as well as CT, MRI and US studies. Former manager of Clinical Research Division in Radiology. Computer skills include use of Microsoft Office suite including Access, Java and HTML. Excellent interpersonal and organizational skills.

Areas of Strength

Monitoring single and multi-site Phase I and 2A pharmaceutical studies, thoracic and abdominal aortic aneurysm endograft repair, homemade stentgrafts, stents, contrast agents, interventional radiology procedures, Access database creation and use.

Experience

ICON Development Solutions ®
Sr. Clinical Research Associate 2006-present

Perform and coordinate all aspects of clinical monitoring including identify, select, initate, and closeout appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs, applicable regulations and the principles of Good Clinical Practice. Involved , when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.

Epcom Corporation, Troy, MI
contracted to Pfizer, Inc.
Clinical Research Associate 2001-2006

Responsible for the quality of information gathered during clinical trials at Pfizer, Inc. including: educating the hospital staff of proper study procedures; verifying all documented information on each patient; investigating and clarifying missing information; reformatting data for input into computer database for statistical analysis; monitor site staff; answer questions regarding protocols and procedures; assist with new patient enrollment; coordinate travel.

University of Michigan Medical Center Ann Arbor, MI
Administrative Associate I 2000-2001

Supervise clinical research coordinators and manage the Clinical Research Program in Radiology, interpret and implement investigational protocols, and responsible for pre-award activity. Coordinate all aspects of clinical trials for pharmaceutical and device protocols. Maintain MS Access database of investigational studies and IRB submissions to better track departmental research activity.

University of Michigan Medical Center Ann Arbor, MI
Radiology Clinical Trials Coordinator 1997-2000

Coordinate all aspects of drug and device clinical trials in radiology, including Institutional Review Board applications, informed consent documents, budget development, procedure and follow up scheduling and case report form documentation. Maintain device inventory. Assist primary investigator in the creation of endovascular stentgrafts. Developed patient tracking web page and database for clinical trials patients in multidisciplinary clinic.

University of Michigan Medical Center Ann Arbor, MI
Anesthesia Tech II 1996- 1997

Set up and operate anesthesia equipment during surgical procedures for all anesthesia service. Assist staff with equipment set up including arterial pressure lines, monitors, blood warmers, rapid infusers and cell savers. Trouble shoot anesthesia equipment and evaluate new equipment. Assist medical staff in preparing patients for surgery using sterile. Obtain blood samples and perform routine diagnostic tests.

University of Michigan Medical Center Ann Arbor, MI
Radiology Special Procedures Assistant 1992- 1996

Prepared sterile trays and necessary equipment for vascular and neurological diagnostic and interventional procedures, prepped and draped patients for procedure and monitored patient vital signs. Maintained room stock supplies and ordered supplies from Material Service Center.

* United Way Division Coordinator 1993
* Exemplary Performance Award 1995

University of Michigan Medical Center Ann Arbor, MI
Food Service Supervisor 1991- 1992

Oversaw the preparation and delivery of patient meals, ordering of stock and food supplies daily, recorded time sheet for payroll, hired and disciplined employees and other miscellaneous duties. Quality Improvement Team member overseeing nourishment room use evaluation.

Metro Rehab Dearborn Heights, MI
Athletic Trainer 1991

Assisted the staff physical therapists with daily treatment programs using various modalities and exercise programs.

University of Michigan Medical Center Ann Arbor, MI
Diet Clerk 1983- 1991

Updated computerized diet, infant formula and nourishment lists; processed requests for new patient meals, diet changes, or additional food items; and miscellaneous typing and census information.

* Developed task procedures for computerized Diet Entry System 1986
* United Way Division Coordinator 1987.

Chelsea High School Chelsea, MI
Athletic Trainer 1984- 1990

Supervised the prevention, care and treatment of athletic injuries for all sports teams; provided medical coverage for all home events and assisted the athletic director in preparation for and running of athletic events.

Education

Eastern Michigan University Ypsilanti, MI
Bachelor of Science, Sports Medicine April 1988