999 Main Street
Any Town, NY 99999
PH: 999.999.9999
FAX: 999.999.9999
Email: email@gmail.com

John Harris

Experience

ABC Inc.
Any Town, NY
Clinical Research Associate Jul 2008-Jan 2010

• Analyze and evaluate clinical data including Case Report Forms (CRF) and source documents, to ensure subject safety, investigator compliance, and site adherence with the study drug protocol, overall clinical objectives, and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
• Coordination for sites.
• Prepare, review, follow-up, and report on Adverse Events (AE), Severe Adverse Events (SAE) reports.
• Acquire specific clinical and therapeutic knowledge related to studies monitored.
• Conduct Pre-Study (Qualification), Site Initiation, Interim and Close-Out monitoring visits.
• Ensure complete and thorough study drug accountability and reconciliation.
• Manage trip reports, letters, query resolutions and expenses.
• Manage site TMF contents and work with sites to ensure communication requirements between site and IRB are adhered to.
• Provide support and timely follow-up for the implementation of clinical protocols, data collection systems, pre-post audits, quality assurance activities, and final reports.

XYZ Corp.
Any Town, NY
Clinical Research Associate Sept 2007 – Mar 2008

• Participated in the management of assigned clinical trials.
• Responsibilities included, but not limited to, abstracting, assembling and organizing research data while monitoring the clinical course of patients entered onto research protocols.
• Participated in protocol development with a particular focus on data collection.
• Prepared reports on individual patients or a study population in response to investigator requests and assisted with the preparation of adverse event reports.
• Prepared for and participated in audits of assigned studies and assists with the preparation of annual protocol renewal requests and, or termination reports.
• Submitted research data in a timely manner to external affiliates, agencies, sponsors and, or Institutional Review Boards as needed.

BCD Inc.
Any Town, NY
Clinical Research Associate – Regional Home-based   Jan 2007 - July 2007

• Responsible for monitoring the conduct of clinical research studies.
• Visit sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to terminate studies.
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.
• Performs investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
• Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites.
• Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports.
• Creating accurate and user-friendly study documentation from knowledge and understanding of the protocol, standardized formats, software applications and SOPs.
• Generate reports for site and project management using Crystal reports and Info View.

Education

Aug 2009-May 2010 University of Colorado, Boulder
Post Baccalaureate Studies
Aug 2008-Jan 2010 University of Wisconsin, Madison Clinical Research Associate Professional Development Program
Jun 2004-May 2008 University of California, San Francisco BSc Microbiology Chemistry Minor Graduated May 2008
Aug 2000-May 2004 New York High School, New York, NY HS Diploma, May 2004

Skills

• Proficient in Microsoft Office and Apple Work: Word, Pages, Excel, Numbers, PowerPoint, and Keynote.
• Electronic Data Capture: Meta data & Data Trak.
• GCP and ICH Guidelines.

References

Available Upon Request

Click to download the Clinical Research Associate Resume Sample Three in PDF.

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