The document provides a summary of Donna Harakal's professional experience and qualifications. She has over 15 years of experience as a clinical research nurse and coordinator, leading numerous drug and device studies across various medical disciplines at Northwestern University. Her experience includes recruiting and screening subjects, obtaining consent, supervising data collection, ensuring regulatory compliance, and serving as a liaison between research staff and administrators. She has a Bachelor of Science in Nursing degree and is certified as a clinical research coordinator and psychiatric mental health nurse.
MPH candidate of Boston University School of Public Health concentrating in biostatistics searching for data analysis position. Experience with using SAS, R and Epidata to perform data management and analysis; experience with using UCINET to perform network analysis; 2-year epidemiological survey background in the field of congenital disease, cardiovascular disease and maternal &children health; collaborative approach working with health providers.
o address family history collection, interpretation, and application in busy primary care practices, NCHPEG has collaborated collaborating with the March of Dimes, Genetic Alliance, Harvard Partners, and the Health Resources and Services Administration to develop and evaluate a novel family history tool that focuses on prenatal and neonatal health. The tool helps to improve health outcomes for the female patient, fetus, and family by providing clinical decision support and educational resources for risk assessment based on family history. A set of screenshots and an overview of the module can be reviewed via this downloadable PPT.
To address family history collection, interpretation, and application in busy primary care practices, NCHPEG has collaborated collaborating with the March of Dimes, Genetic Alliance, Harvard Partners, and the Health Resources and Services Administration to develop and evaluate a novel family history tool that focuses on prenatal and neonatal health. The tool helps to improve health outcomes for the female patient, fetus, and family by providing clinical decision support and educational resources for risk assessment based on family history. A set of screenshots and an overview of the module can be reviewed via this downloadable ppt.
MPH candidate of Boston University School of Public Health concentrating in biostatistics searching for data analysis position. Experience with using SAS, R and Epidata to perform data management and analysis; experience with using UCINET to perform network analysis; 2-year epidemiological survey background in the field of congenital disease, cardiovascular disease and maternal &children health; collaborative approach working with health providers.
o address family history collection, interpretation, and application in busy primary care practices, NCHPEG has collaborated collaborating with the March of Dimes, Genetic Alliance, Harvard Partners, and the Health Resources and Services Administration to develop and evaluate a novel family history tool that focuses on prenatal and neonatal health. The tool helps to improve health outcomes for the female patient, fetus, and family by providing clinical decision support and educational resources for risk assessment based on family history. A set of screenshots and an overview of the module can be reviewed via this downloadable PPT.
To address family history collection, interpretation, and application in busy primary care practices, NCHPEG has collaborated collaborating with the March of Dimes, Genetic Alliance, Harvard Partners, and the Health Resources and Services Administration to develop and evaluate a novel family history tool that focuses on prenatal and neonatal health. The tool helps to improve health outcomes for the female patient, fetus, and family by providing clinical decision support and educational resources for risk assessment based on family history. A set of screenshots and an overview of the module can be reviewed via this downloadable ppt.
I have recently relocated to the Denver, Colorado area and I am actively seeking a position, in research, that can challenge and utilize the professional knowledge I have acquired over the past four years. I am a self motivated, ambitious young professional who has worked very hard to become an effective asset and team member to each organization which I have been a part of. Since my graduation with a BS Clinical Research, I have worked in a variety of positions including corporate CRO research (INC Research), direct clinical care (Nursing Assistant at UNC and Duke Hospitals), and most recently, Clinical Research on the site level with the Duke University Cardiothoracic Surgery Research Team. My previous team lead and research practice manager, included as references on my resume, will likely cite my ability and willingness to learn quickly, interact with subjects/patients in a personable manner, and develop productive working relationships with my team members. I pride myself on my work ethic and enjoy working around others that inspire that same dedication.
I have recently relocated to the Denver, Colorado area and I am actively seeking a position, in research, that can challenge and utilize the professional knowledge I have acquired over the past four years. I am a self motivated, ambitious young professional who has worked very hard to become an effective asset and team member to each organization which I have been a part of. Since my graduation with a BS Clinical Research, I have worked in a variety of positions including corporate CRO research (INC Research), direct clinical care (Nursing Assistant at UNC and Duke Hospitals), and most recently, Clinical Research on the site level with the Duke University Cardiothoracic Surgery Research Team. My previous team lead and research practice manager, included as references on my resume, will likely cite my ability and willingness to learn quickly, interact with subjects/patients in a personable manner, and develop productive working relationships with my team members. I pride myself on my work ethic and enjoy working around others that inspire that same dedication.
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
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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
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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