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cott D. Zerzanek

OBJECTIVE

Interested in furthering my clinical research skills in a both dynamic and challenging environment where I can use my leadership and natural curiosity to growprofessionally as well as within the company ultimately towards great ideas andopportunities

WORK EXPERIENCECovidien, Bedford, MA 11/06-PresentField Clinical Research AssociateSuperior time management, communication/problem solving, adapting to change andcomputer skillsProficient in review of regulatory documents, medical records and electronic medical record systemsKnowledge and understanding of FDA and ICH Guidelines for Clinical Trials, Codeof Federal Regulations as it applies to drug/device clinical trials, Good Clinical Practice Guidelines for drug/device clinical trials, and regulatory documentsfor all aspects of the clinical trial lifetimeExperience using electronic data capture systems and clinical trial management systemsConduct prequalification, initiation, interim monitoring and closure visitsExperience in FDA audit site preparatory visits, onsite FDA audits, and FDA pane

l meetingsAttend live cases in operating suite (cranial, spinal cord, vascular, lung resection, abdominopelvic) on a regular basis for assigned sitesAttend adverse event Clinical Events Committee adjudication meetingsJ Tyson & Associates, Salem, WI 01/05-11/06Clinical Research AssociateLiaison between Field CRA / site and management personnel on issues related to protocol adherence, site management, CRF review and submission of data forms. Track UADE/SAEs, AEs, Protocol Deviations, visits, subjects, CRFs, queries, test article, etc. as required per protocol for 5 studies and a total of 175 national sites concurrently.

Initiated contact with potential study participation sites

Tracked, collected and reviewed study start-up regulatory documentsReview of prequalification, initiation, interim monitoring, and closure visit reportsPlanned and presented at investigator meetingsDaily contact with site research coordinators, research managers, regulatory specialists

EDUCATION

University of Wisconsin - Parkside, WIBachelor of Science in Business Management - Marketing 05/03 Bachelor of Sciencein Biology - Molecular 05/01

RELEVANT TRAINING / COURSES

Experience in cardiovascular, neurological , thoracic, peripheral vascular, bariatric, plastic surgery, abdominopelvic therapeutic areas 11/06-PresentStrategies for Managing Difficult Clinical Research Sites 03/10Electronic Medical Records and Source Document Verification: Approaches for Ensuring Document and Source Part 11 Required 11/09Trial Master File (TMF): Set-up and Maintenance 11/09Developing & Negotiating Study Budgets for Clinical Research Sites 06/09Use of Note to Files in Clinical Trial Essential Documentation 06/09

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Adverse Event Monitoring for CRAs 05/09Performance Improvement Monitoring Model 10/08Source Documenation - What is Adequate & Accurate? 10/08ACRP-CCRA 09/08Clinical Research Education Conference at Northwestern University 05/08AORN Operating Room Protocol / Blood borne Pathogen / HIPAA certified 04/07