Medical Training
Resume:
FAIR OAKS, CA *****
PHONE: 916-***-****
EMAI L: *****@*****.***
SOF IA M I LUNOV ICH, CCRP
ED UCAT ION
August 2009 – May 2013
Saint Mary’s College of California, Moraga, CA
o Bachelor’s Degree, with honors
o Graduated magna cum laude
C ERT I F ICAT IONS / SK I L LS
o The Society of Clinical Research Associates, Inc., Certified Clinical Research
P rofessional Certification, April 2014
o Knowledge of H IPAA, FDA and ICH guidelines/regulations
o N I H Clinical Research Training and Medical Education
o CITI Collaborative Institutional Training Init iative
o Electronic Data Collection Systems Proficiency (INFORM, iMedidata, eClinical)
o Electronic Medical Records Review (EPIC)
o Microsoft Office
PROFESSIONAL ASSETS
o Leadership
o Project coordination
o Development of site Standard Operating Procedures and Policies
o Planning and scheduling
o Organization
o Attention to detail
o Protocol management and implementation
o Training
o Site research development
o Exceptional wri ting abilities
o Experience with all 5 phases of research
o Enrollment of over 350 total research participants
AREAS OF EXPERT ISE
o Cardiology
o Neurology
o Oncology
o Therapeutics
o Diagnostics
PROFESSIONAL EXPER I E NCE
Northern California PET I maging Center / Sutter Roseville Medical Center
Certified Clinical Research Coordinator
May 2011-Present
In this highly intensive position, I have acted as the sole project coordinator for the last two
years, managing the implementation of various research protocols in the fields of
cardiology, neurology, oncology and diagnostic imaging.
o Development of site Standard Operating Procedures and policies
o Overall management and implementation of research protocols for both therapeutic
and diagnostic t r ials
o Organize, plan and manage work f low of various personnel including imaging
technicians
o Ensure that all clinical and regulatory procedures are followed and documented
o Abstract data from medical sources to complete study forms and summarize the
clinical course
o Collect data from study participants through patient interviews
o Obtain informed consent from study participants
o Recruitment, screening and enrollment of study participants
o Enrollment of over
o Ini tiate procedures as required by protocol
o Act as liaison for physicians, nurses, technicians by providing accurate and updated
i nformation regarding protocols
o Responsible for coordinating with the Institutional Review Board (IRB), medical
s taff and sponsors to ensure that all clinical and regulatory procedures are followed
and documented
o Report Serious Adverse Events per protocol and IRB guidelines
o Develop informed consent forms and source documents consistent with IRB and
sponsor requirements
o Prepare initial submissions, amendments, revisions, annual reports and closure
reports for IRB submission
o Prepare regulatory files and patient study charts for site visits
o Participate in education and t raining of new investigators and staff
o Assist with budget preparation
o Track and maintain investigational product
o Order study drug, supplies and equipment
o Maintain an excellence in patient care and assistance
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