Medical Device

Career Profile

A current Certified Clinical Research Coordinator (CCRC) seeking a medical

writing position. Has exceptional writing aptitude, knowledge of United

States Food and Drug Administration (FDA) and International Conference on

Harmonization (ICH) regulations and guidelines, and medical device

experience. Drafts, reviews, evaluates, and modifies study protocols and

Informed Consent Forms (ICFs). Prepares regulatory documentation and

submissions to Institutional Review Boards (IRBs) and sponsors. Highly

motivated to continue medical writing education and ongoing science

education through subsequent American Medical Writers Association (AMWA)

Pharmaceutical and Science Fundamentals certification, The University of

Chicago Graham School of General Studies Medical Writing and Editing

certification, and the Northwestern University School of Continuing

Studies.

Professional Experience

02 August 2007-Present

Clinical Research Coordinator

Chicago Institute of Neurosurgery and Neuroresearch (CINN)

. Coordinate the conduct of medical device and other research protocols

according to International Conference on Harmonization/Good Clinical

Practice/Food and Drug Administration (ICH/GCP/FDA) regulations

. Draft, review, evaluate, and modify protocols and Informed Consent

Forms (ICFs) and conduct process of consent

. Prepare regulatory documentation, including financial disclosures and

curricula vitae (CVs)

. Prepare documents for submission to the Institutional Review Board

(IRB) and sponsor and maintain regular correspondence regarding

continuing review, adverse events (AEs), sponsor reports, protocol

amendments, protocol deviations, and Informed Consent Form (ICF)

modifications

. Screen for eligibility criteria and recruit potential study subjects

. Conduct intra-operative study activity

. Obtain applicable source documents, including ancillary services

reports

. Record all necessary data, including Adverse Events (AEs) and

associated causality and severity as determined by Principal

Investigator (PI), on applicable Case Report Forms (CRFs) or

electronic Case Report Forms (eCRFs), and report to sponsor and

Institutional Review Board (IRB) in applicable cases

. Schedule subject visits within windows designated by protocol

. Develop presentations for clinical research and clinical staff

personnel compliance and poster abstracts for conferences

. Monitor site compliance with Good Clinical Practice (GCP), Standard

Operating Procedures (SOPs), regulations, and protocol

. Assure subject safety during study

. Coordinate sponsor and regulatory audits

. Maintain confidentiality of protocols and subject information

. Act as liaison between investigators, sponsors, and subjects, and

record and file correspondence

05/01/2006-08/01/2007

Patient Care Technician

Evanston Northwestern Healthcare

. 27 April 2007: Received Service Excellence CARE Award

. Conducted voluntary quality control of electronic medical records in

order to evaluate compliance with internal unit protocols

. Documented promptly and accurately per protocol in electronic medical

records

. Obtained and documented vital signs and weights according to

established unit protocol, MD orders, or RN direction

. Participated with RN in prioritizing and planning patient care

. Utilized aseptic/sterile technique to provide wound care and dressing

application according to plan of care

. Maintained and reinforced oxygen/respiratory therapy

. Performed tube feeding setup, colostomy/ileostomy care, Foley catheter

insertion/care, specimen collection, TED hose application/removal,

blood glucose quality control and monitoring via finger stick

. Notified RN in event of abnormal vital signs or unusual patient

behavior and assisted in administration of care during Rapid Response

or Code Blue

Summer 2005, 2004, 2002

Summer Help

Chickasaw County

. Trained and supervised other employees as a result of acquired skills

and knowledge involving commercial truck driving, physical labor, and

equipment and facility maintenance

Fall 2004-Spring 2005

Undergraduate Research Assistant

The University of Iowa

. Organized confidential psychiatric case files

. Assembled interview materials for Attention Deficit Hyperactivity

Disorder research study

. Retrieved and electronically scanned professional literature in

support of Attention Deficit Hyperactivity Disorder research study

proposal to National Institutes of Health

Education

. The University of Iowa, Iowa City, IA

Bachelor of Arts, Russian, History, 2005

Graduated In 95th Percentile of Class With Honors

. The University of Chicago, Chicago, IL

Offer of Admission, Department of Slavic Languages and Literatures PhD

Program, 2005

Continuing Education and Certifications

Association of Clinical Research Professionals (ACRP) FDA CCRC, 2009

25 September 2007 - Present

Student-At-Large

Northwestern University School of Continuing Studies

. 31 March 2008 - 14 June 2008

College Physics III

General Physical Chemistry

. 7 January 2008 - 22 March 2008

College Physics II

General Inorganic Chemistry

. 25 September 2007 - 15 December 2008

College Physics I

General Chemistry

15 February 2007-10 May 2007

Student

Northwestern Center for Clinical Research of Northwestern University

Feinberg School of Medicine Clinical Research Associate and Clinical

Research Coordinator Training Course

. Introduction to Clinical Research and the Drug Development Process

. Protocol Development and Research Methods

. Clinical Research Personnel, Service Providers, and the Site

Selection Process

. Human Subject Protections and Regulatory Oversight

. Institutional Review Boards, Informed Consent, and HIPPA

. Daily Operations: Clinical Trial Conduct, Monitoring and Record

Keeping

. Recruitment, Retention, Drug Compliance, Accountability & Study

Close-Out

. Safety Monitoring and Adverse Events

. Quality Assurance, Audits, and Inspections

. Role of Clinical Data Management

. Study Budget and Contract Evaluation and Negotiation

. Medical Device Trials: An Overview for CRAs and CRCs

Additional Continuing Education and Certifications

. 03 August 2007: Completed NIH Stroke Scale Test Group A Certification

. 25, 27 July 2007: Completed Office for Human Research Protections

Human Subject Assurance Training

. 20 July 2007: Completed National Cancer Institute Human Participant

Protections Education for Research Teams

. Completed Evanston Northwestern Healthcare IRB Research Modules

. 21 November 2005-29 April 2006: Enrolled at Career Academy School of

Allied Health Technicians, earned titles National Certified Phlebotomy

Technician, IDPH Nurse Aide, and American Heart Association Healthcare

Provider with CPR and AED Certification, and completed additional EKG

Module and Respiratory Module

. Offered phlebotomy externship at John Stroger Community Hospital and

eventual certification as a Registered Phlebotomy Technician (RPT) by

American Medical Technologists

Professional and Educational Affiliations

. Member, American Medical Writers Association Greater Chicago Area

Chapter (AMWA GCAC)

. Member, Association of Clinical Research Professionals (ACRP)

. Member, Phi Beta Kappa

Volunteering/Philanthropy

. 06 August 2007-Present Associate Board Member, Chicago Institute of

Neurosurgery and Neuroresearch Foundation

. Member, Wilmette Community Band

. Board Development Member, Literacy Chicago Associate Board

. Adult Literacy/English as a Second Language Tutor, Literacy Chicago

. Laboratory/Dispensary/Front Desk Volunteer, Community Health Clinic

. Research Volunteer, International Museum of Surgical Science

. Volunteer, Medical Reserve Corps of Evanston

. Docent, Evanston Historical Society

Scholarship

. Designed, researched, and drafted interdisciplinary thesis, Sluggish

Schizophenia: The Abuse of Terminology and Application, supported by

Senior Honors Thesis/Project Grant

. Edited and proofread faculty manuscript and student drafts

. Researched, analyzed arguments, and wrote numerous scholarly papers

and synopses

. 2004, 2003 Helen Fairall Scholarship

. 2004, 2001 U of I Tuition Scholarship

. 2004 UI Foundation Honors Scholarships

. 2003 UI Department Funds/Foundation Scholarship

. Honors Commendation

Student Organizations

Phi Alpha Delta Law Fraternity International

. Created, modified, and directed nationally-ranked recruitment program,

led meetings, and chaired committees as Vice President

. Successfully applied for student government funding, led meetings, and

chaired committees as Treasurer

History Club

. Developed faculty and student contacts, publicized and arranged

organizational meetings, and reestablished formal campus organization

dedicated to history

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