cott D.

Zerzanek
OBJECTIVE
Interested in furthering my clinical research skills in a both dynamic and chal
lenging environment where I can use my leadership and natural curiosity to grow
professionally as well as within the company ultimately towards great ideas and
opportunities
WORK EXPERIENCE
Covidien, Bedford, MA 11/06-Present
Field Clinical Research Associate
Superior time management, communication/problem solving, adapting to change and
computer skills
Proficient in review of regulatory documents, medical records and electronic med
ical record systems
Knowledge and understanding of FDA and ICH Guidelines for Clinical Trials, Code
of Federal Regulations as it applies to drug/device clinical trials, Good Clinic
al Practice Guidelines for drug/device clinical trials, and regulatory documents
for all aspects of the clinical trial lifetime
Experience using electronic data capture systems and clinical trial management s
ystems
Conduct prequalification, initiation, interim monitoring and closure visits
Experience in FDA audit site preparatory visits, onsite FDA audits, and FDA pane
l meetings
Attend live cases in operating suite (cranial, spinal cord, vascular, lung resec
tion, abdominopelvic) on a regular basis for assigned sites
Attend adverse event Clinical Events Committee adjudication meetings
J Tyson & Associates, Salem, WI 01/05-11/06
Clinical Research Associate
Liaison between Field CRA / site and management personnel on issues related to p
rotocol adherence, site management, CRF review and submission of data forms. Tra
ck UADE/SAEs, AEs, Protocol Deviations, visits, subjects, CRFs, queries, test ar
ticle, etc. as required per protocol for 5 studies and a total of 175 national s
ites concurrently.
Initiated contact with potential study participation sites
Tracked, collected and reviewed study start-up regulatory documents
Review of prequalification, initiation, interim monitoring, and closure visit re
ports
Planned and presented at investigator meetings
Daily contact with site research coordinators, research managers, regulatory spe
cialists
EDUCATION
University of Wisconsin - Parkside, WI
Bachelor of Science in Business Management - Marketing 05/03 Bachelor of Science
in Biology - Molecular 05/01
RELEVANT TRAINING / COURSES
Experience in cardiovascular, neurological , thoracic, peripheral vascular, bari
atric, plastic surgery, abdominopelvic therapeutic areas 11/06-Present
Strategies for Managing Difficult Clinical Research Sites 03/10
Electronic Medical Records and Source Document Verification: Approaches for Ensu
ring Document and Source Part 11 Required 11/09
Trial Master File (TMF): Set-up and Maintenance 11/09
Developing & Negotiating Study Budgets for Clinical Research Sites 06/09
Use of Note to Files in Clinical Trial Essential Documentation 06/09
Adverse Event Monitoring for CRAs 05/09
Performance Improvement Monitoring Model 10/08
Source Documenation - What is Adequate & Accurate? 10/08
ACRP-CCRA 09/08
Clinical Research Education Conference at Northwestern University 05/08
AORN Operating Room Protocol / Blood borne Pathogen / HIPAA certified 04/07