Theresa M.

Karl
145 Monson Road
Wilbraham, MA 01095
413-599-1660
OBJECTIVE: Clinical Trials Coordinator who can be the anchor of a busy
research team. Objective is to continue to build on experience that
includes Phase I, II, and III study management, clinical work and data
collection for CRFs, SAEs, and large electronic NIH/NCI databases.
PROFESSIONAL EXPERIENCE
Outcomes Health Solutions
December 2008 -June 2009
Field Reviewer
o Review patient charts, collected data for Medicare/Medicaid related
patients, uploaded data. This position required that I visit a
different site each day.
University of Massachusetts Medical School, Cancer Clinical Research
Office
September 2007 - April 2008
Clinical Research Nurse Coordinator
o Coordinated several clinical trials including breast, pancreas,
prostate, colorectal and lung trials
o Determined eligibility of patients for each study and used expert
communication skills by coordinating all required tests and procedures
with medical staff
o Completed CRFs and maintained CRF binders. Assisted in IRB
applications and renewals
o Maintained contact with drug companies to ensure that work was
completed correctly and that queries and SAEs were completed in a
timely fashion
o Supervised one CRA
Outcomes Inc
January through July, 2007
Field Reviewer
o Reviewed patient charts, collected and uploaded data
University of Massachusetts Medical School, Department of Cancer
Biology
June 2005 to December, 2006
Research nurse
o Coordinated 8 clinical trials and supervised one data coordinator.
Areas of interest were: prostate, colorectal, breast and pancreas
cancer clinical trials. Member of CALGB, ACOSOG, RTOG, NSABP
University of Massachusetts Medical School, Department of Surgery
July 2003 to June 2005
Research Project Director
o Coordinated several industry-sponsored and investigator-initiated
clinical trials. The largest project was a large infection control
study of 100 post transplant subjects. This position required
collection and management of data, all administrative details
including IRB applications, renewals and study closures.
o This position required expert communication, organizational and
technical skills.

Yale University School of Medicine, Department of Medical Oncology

July 2002 to July 2003
Research Coordinator
o Project leader in phase I and II oncology trials
o Primarily responsible for all academic and industrial lung and phase
I trials
o Met with clinical scientists from Millennium, Wyeth, Regeneron,
Bettelle-Zvena early in the development process to ensure feasibility
of conducting such a trial in a particular environment according to
standard operating procedures
o Point person for pharmaceutical company staff and clinic staff
o Determined eligibility of subjects, instructed MDs and NPs to
collect very particular data, determined dose modifications and
subsequently determined continuation or end of study for patients

o Worked closely with data management team to ensure that CRFs were
completed within established timeline
o Maintained daily contact with pharmaceutical companies as research
is an ongoing process and there needs to be timely resolution of
queries and completion of all safety reports and SAEs.
Yale University School of Medicine, Department of Transplant Surgery
March, 2001 to July 2002
Research Coordinator
o Contracted as point person to complete pharmaceutical trials that
tested the efficacy of new transplant drugs, or investigated new uses
for drugs already on the market
o Contact person for Novartis, Fujisawa and Wyeth, and their CROs that
incluced Covance and Barton and Polanski
o Directed institutional staff regarding their roles in completing
protocols to ensure that the drug was properly distributed and that
all data points were collected in a timely fashion.
o Reported all SAEs within the 24-hour time frame and demanded by
industry and completed them with the expertise that only an RN could.
Oral Cancer Center Grant