Clinical Research Data Entry
Resume:
SANDRA D. HALVORSON
St. James, MN 56081
507-***-**** (home) or 507-***-**** (cell)
Email: ************@*****.***
SUMMARY
Strong administrative experience in the medical device industry; organization and management of clinical study documentation, in-house and on site audits/monitoring of clinical sites, critical document submissions to appropriate management levels, and meeting/travel arrangements. Strengths are in the areas of company operating procedures, use of various office equipment, data base systems such as; CTMS, RDC, Department Docs, Agile, Business Objects, communication with management as well as customers/clients in the business industry. A team player, who is also able to work well independently, or in a group.
ACCOMPLISHMENTS
Administrative
Answer five line phone system
Scheduled and changed appointments
Entered data into various databases
Prepared reports for monthly Senior Staff meetings
Maintained Master Files for multiple sites to assure all critical documentation is on file
Scheduled site visits
Review and prepare documentation for data entry, data entry of information, and updating reports
Managed vehicle fleet for maintenance
Managed facility and safety inspections of premises
Ordered and picked up supplies for various research projects
Coordinated filing projects
Clinical
Prepared required information for site studies; case report forms and monitoring plans
Wrote the Clinical Evidence Report, which secured TUV approval for the Medtronic Contour 3D
Reviewed documents to ensure all critical documents
Reviewed and updated agreements with sites
Prepared slide presentations for training
Updated and completed Monitoring Plans to compliment updated protocols
Reviewed Standard Operating Procedures and updated to company standard
Managed and monitored clinical studies at various sites, prepared written monitoring reports in conjunction with annual visits, and worked with site coordinators in the completion of Case Report Forms, training as needed for site, end-of-study site closure and reports
Work with sites, core labs, and General Counsel in the preparation of legal contracts
Worked on Project teams for various product phases, researching the database for literature/articles to aid with in writing clinical evaluations for TUV and other regulatory bodies
Ensured compliance of protocol, Institutional Review Board directives, and required regulations as necessary
Worked with international site coordinators in Australia and New Zealand for both long-term studies and ongoing clinical studies to ensure all critical documents were complete and on file at site and in-house
Worked with clients to obtain critical documents for activation
Participated as member of Risk Analysis teams
Work with clinical team on study closure requirements from the business side
Completed final reports to the sites and/or FDA if required
Assisted the Regulatory team in obtaining FDA Approval on specific clinical studies
EMPLOYMENT
Jeane Thorne Sep 2015 to Present
Sr. Clinical Research Associate Jan 2015 to July 2015
Neovasc
Office and Administrative Specialist March 17, 2014 to Dec 2014
Minnesota Department of Natural Resources
Front Desk Reception Feb 1, 2014 – March 15, 2014
Springfield Dental Clinic (through Jean Thorne)
Clinical Research Associate Aug 2012 – April 2013
Coloplast, Corp.
Clinical Research Specialist August 2005 – August 2012
Medtronic, Inc.
EDUCATION
Walden University, Baltimore, MD – Master of Healthcare Administration – February 2011
University of Phoenix, Phoenix, AZ – Bachelor of Science Healthcare Administration – May 2008
Western International University, Phoenix, AZ – AA in Business 2006
Other classes/courses and conferences: WordPerfect, Infomaker, Excel, Power Point, Visio, LifeScience Alley, SynQuest, Oracle Clinical (RDC), CTMS, Department Documentation, Agile, Fundamentals of Clinical Research, and CITI.
Associations & Memberships-
-LifeScience Alley
-Medical Device Alliance
-Ambassador - University of Phoenix
-Ambassador – Walden University
Minnesota 4-H Volunteer Services:
-4-H Horse Project Leader 17 years – Scott County
-Past PDC President
-Hippology Judge at State 4-H Horse Show
-Judge for Project Bowl the last 3 years
-Assisted with Judging Certification and / or recertification of current Judges
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