1. Donna Harakal, B.A., B.S.N., R.N., B.C., C.C.R.C
donna.harakal@gmail.com
PROFESSIONAL EXPERIENCE
Northwestern University – Chicago, IL January 2008 – Present
Clinical Research Nurse
 Lead coordinator for approximately 29 studies, both drug and device trials for disciplines including bariatrics,
rheumatology, autoimmune, nephrology, otolaryngology, infectious disease, cosmetic, and pulmonary
 Responsible for subject management, including: recruiting subjects; assessing appropriateness of subjects for
enrollment into various studies; scheduling subject visits with subjects and research staff; assisting subjects in
navigating the research and clinical setting; securing appropriate clinical space for study visits; obtaining informed
consent from subjects; supervising data collection and reporting; and ensuring adherence to all regulatory
requirements and sponsor protocols; oversee and maintain accurate accountability over investigational product and/or
research devices; great attention to detail, and accuracy to source documentation; abide by all GCP requirements
 Assist in orientation of new personnel; act as a resource to research subjects, physicians and other clinic personnel
 January 2015 responded to a FDA audit resulting in no findings
 Extensive experience collaborating with physicians, principal investigators, and other research professionals to
determine the most efficient means to implement study protocols while adhering to regulatory guidelines, maintaining
quality and safety; serve as the liaison between investigators/research staff and departmental administrators in
assessing resources and organizing/implementing and conducting clinical trials/research activities; acts as a resource
for external staff with utilizing center services during study initiation and implementation (recruitment, regulatory,
financial)
 Assist principal investigators in evaluating individual study budgets, and determining the feasibility of conducting
clinical trials with the available personnel, services, and resources
 Responsible for facilitating monitor visits overseeing research trials; regular contact with sponsor representatives to
ensure adherence to study goals
 Experience editing and revising informed consent forms; support to regulatory team on assisting with IRB submissions
 Acts as a support and resource to peers and external departments in providing insight, assist in data auditing, and
implement process improvements
University of Chicago – Chicago, IL June 2001– November 2007
Senior Project Research Coordinator
 Autonomously responsible for large portion of this site’s data collection; selected and evaluated subjects for inclusion
into federally funded genetic studies; oversaw completion of screening forms, assigned screens to staff for follow up,
monitored progress of potential individuals and families toward enrollment; evaluated subjects utilizing standardized
semi-structured interview and made clinical judgments as to best estimate of diagnosis as well as coordination of pre-
enrollment work-up for subjects; obtained psychiatric/substance use histories and treatment records; oversaw and
managed collection of blood samples and performed phlebotomy both in office and independently out in the field
 Responsible for clinically training staff in: (1) subject recruitment; (2) screening subjects using DSM IV criteria; (3)
observing and evaluating 4 hour diagnostic interviews; (4) evaluating best estimate of subject diagnosis from
diagnostic interviews; (5) obtaining family history interviews in assessing mental illness; (6) data entry; and (7)
development of reports indicating progress of study
 Responsible for training staff in non-clinical duties, including: (1) subject files; (2) request for medical records; (3)
mailing of blood kits; and (4) submitting required documents for study continuation and/ or amendments to the
Institutional Review Board
 Collaborated with principal investigator in managing studies, including: developed subject recruitment, advertising and
community outreach; provided weekly status reports to principal investigator; initiated communication with other
national sites to share status reports; transcribed written data into digital form; organized the data collected and
transferred to psychiatrists and geneticists for further evaluation and analysis; responsible for maintaining compliance
with the protocols of the University of Chicago Institutional Review Board and the National Institute of Mental Health

2. Donna Harakal CV
Page 2 of 3
Northwestern University – Chicago, IL May 1999 – May 2000
Research Assistant
 Responsibilities included implementation of study protocol, data collection and appropriate documentation, patient
recruitment and assessing preliminary criteria using DSM-IV for initial phone screenings. List of research projects
available upon request
Northwestern Memorial Hospital – Chicago, IL July 1996 – March 2005
Resource Coordinator
 Served in a leadership capacity including identification and reporting of trends. Worked directly with clinical nurse
manager and served as acting supervisor in her absence. Integral member of the facility and departmental quality
intervention teams. Instrumental in development and implementation of hospital-wide and department specific health
and safety standards in the form of policy and protocol as Resource Coordinator for the unit. Appointed by the Director
of Nursing, Psychiatric Institute, as a Member of the Division of Patient Care, Nursing Practice Committee, and
Standards of Care Committee
 Direct patient care responsibilities included coordination of patient/ family education, development of staffing needs
using cost effective measures based on protocol including scheduling, and various means of maintaining quality of
care with available resources. Effective communication at the interdisciplinary level throughout the organization
essential to achieving these goals
 Also served as a transitional Patient Care Coordinator, in addition to performing the Resource Coordinator role. As a
Patient Care Coordinator, functioned as a clinician as well as an advocate. Responsible for day to day contact with
insurance companies to maintain patient funding. Collaborated with physicians, social workers, and occupational
therapists in treatment planning conferences. Arranged family meetings, along with being in contact with outside
agencies for housing placement, in addition to total daily care. As a utilization manager, provided current clinical
information regarding rational which met acute inpatient psychiatric criteria when appropriate
Northwestern Memorial Hospital – Chicago, IL January 1993 – July 1996
Staff Nurse
 Responsible for patient/ family education, patient assessment and intervention in an acute psychiatric care setting,
eventually leading to a charge nurse role. Assumed additional responsibilities directed toward career development
leading to the Resource Coordinator position. Participated in a research project involving the measurement of
medication compliance in relation to re-admission after discharge. An integral part of the study protocol centered
around patient medication education and identification
Rush Presbyterian-St. Luke Medical Center – Chicago, IL March 1992 – November 1992
Nurse Assistant
 Assisted nurses on a pediatric intensive care unit in blood pressure monitoring, patient feeding, charting various vital
statistics, activities of daily living, collection of specimens, etc.
EDUCATION
 Valparaiso University-Bachelor of Science in Nursing 1990-1992
 Purdue University Calumet- Bachelor of Arts in Clinical Psychology 1984-1989

3. Donna Harakal CV
Page 3 of 3
LICENSING / CERTIFICATIONS / MEMBERSHIPS
 Registered Professional Nurse in State of Illinois: License #041-274137: Expires 5/31/16
 Academy of Clinical Research Professionals Certified Clinical Research Coordinator Certification: Expires 5/31/17
 Board Certification as a Psychiatric and Mental Health Nurse by the American Nurses Credentialing Center
Certification: #2005001087: Expires 11/30/20
 CPR certified: Expires June 2017
 American Psychiatric Nurses Association Member: Member #2354: Expires 6/30/16
TRAINING
 Collaborative Institutional Training Initiative (CITI) Northwestern University: 12/13 Expires 12/16/16
 Good Clinical Practice Northwestern University: 12/10, 1/16 Expires N/A
 Clinical Research Coordinator Basic Training Northwestern University: 1/08 Expires N/A
AWARDS / COMMUNITY SERVICE
 Northwestern University Service Excellence Certificate-Chicago, IL 2015
 Human Rights Committee, New Hope Center- Dolton, IL 2011-2012
 Volunteer services at Little Brothers of the Elderly-Chicago, IL 2009-2010
 Volunteered as Research Assistant at Northwestern University 1998-1999
 Participated in Diet and Hormone study for breast cancer research conducted through Northwestern University
 Participated in a Bone Density Study, secondary to the Diet and Hormone study for breast cancer research conducted
through Northwestern University
 Volunteered services at Tri-City Community Mental Health Center from August 1989 - June 1990
REFERENCES
 Available upon request