Medical Device Administrative Assistant
Resume:
TRAVIS JACKSON
Garner, North Carolina 27529
Mobile: 919-***-**** *******@*****.***
SUMMARY
Enthusiastic Clinical Research Professional with more than five years of experience which include remote query resolution, late phase medical device studies and a phase III double blind drug accountability study. In addition, I have an extensive health care and laboratory background.
PROFESSIONAL EXPERIENCE
PAREXEL-Morrisville NC 2011-present
In-house Clinical Research Associate
• Support and collaborate with CRA regarding onsite issues and actions items.
• Act as in-house site support by responding to inbound calls and emails which address issues either directly or inform appropriate team member.
• Responsible for the completeness and quality of the in-house site specific files.
• Assist sites in resolving queries in the EDC and study specific questions regarding the protocol.
• Monitor’s site progress regarding protocol compliance and recruitment.
QUINTILES-Morrisville NC 2010-2011
In-house Clinical Research Associate
• Collected, tracked and reviewed regulatory documents used to monitor for enrollment of investigative sites.
• Ensured that sites are recording data from source documents in accordance with study plans.
• Ensured CRO/ Sponsor SOPs were followed in the collection of data and the resolution of data queries in accordance with study plans.
• Monitored site and subject progress, including documentation and reporting of adverse events; recommended corrective action as appropriate.
• Performed remote interim monitoring calls to assist CRAs in monitoring site activities and ensures sites are following protocol, SOPs and federal guidelines.
KENDLE INTERNATIONAL-Durham NC 2007-2009
Clinical Research Associate (CRA)
• Reported to Lead CRA / Project Leader as appropriate.
• Completed monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification.
• Managed study site activities and provides ongoing updates of site status to Lead CRA / Project Leader.
• Managed the trial master file for a study.
• Performed Drug Accountability exclusively on a study.
• Collected, reviewed and tracked drug accountability documents when required.
• Completed Case Report Forms on Lab work for clinical study.
• Ensured proper storage, dispensation, and accountability of all Investigational Products(s) and trial related materials.
KENDLE INTERNATIONAL-Durham NC 2006-2007
In-house Clinical Research Associate
• Assisted Query Management staff in ensuring that efficient and accurate management of data clarification forms within CTMS database.
• Communicated with site study staff to respond to questions regarding the protocol or the clinical trial.
• Assisted with the resolution of Data Clarification forms with the site staff.
• Help to facilitate queries generated by data management for resolution.
• Assisted study coordinators with questions or concerns regarding the protocol.
• Acted as a liaison between clinical research associates, study coordinators and data management.
• Helped review regulatory documents to ensure that each document was complete and accurate prior to transmission to the sites.
• Tracked and integrated queries on studies.
• Utilized current study documentation including protocols, Case Report Forms (CRFs) to assist sites with resolving queries.
• Updated all relevant tracking system on an ongoing basis.
QUINTILES-Morrisville, NC 2006-2006
Site Relations Coordinator
• Verified contact information for site specialist.
• Made outbound calls to study coordinators, research nurses and physicians for status regarding confidential disclosure agreements and site questionnaires.
• Utilized excel input contact data for site specialist.
• Participating in feasibility study by submitting clinical trial documentation for possible site participation.
• Updated sites contact information and address in the database
QUEST DIAGONOSTICS-Raleigh NC 2002-2008
Leading provider of diagnostic testing
Specimen Processor
• Prepared specimens for diagnostic testing.
• Processed lab specimens for diagnosis via data entry.
• Quality checked lab requisitions.
• Aliquoted lab specimens for testing.
• Also familiar with laboratory ranges and an overview of clinical laboratory improvement amendments.
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TRIUMPH LLC-Raleigh NC 2005-2006
Outpatient Psychiatric Clinic
Clinical Administrative Assistant
• Scheduled appointments for clients to see psychiatrist.
• Answered multiple phone lines to assist patients with medication refills and scheduling.
• Verified Insurance information.
• Assisted in transcribing consultations
LIPOSCIENCE, INC-Raleigh NC 2003-2004
Creator of NMR Lipoprofile test
Laboratory Accessioner
• Input Lipoprofile test data for diagnostic purposes.
• Prepped lab specimens for analysis and testing.
• Archived lab documentation via scanning.
• Completed quality checks and entered data for compliance and accuracy.
THERAPEUTIC EXPERIENCES
Crohns Disease
Medical Device
• Carotid Artery Disease
Systemic Lupus Erythematosus
• Drug Accountability
Knee Replacement
• Training-Degenerative Arthritis
Hypertension
● Training-Query Management
Diabetes Mellitus-Type 2
• Training-Query Management
EDUCATION
B.A., English, North Carolina State University, Raleigh NC
COMPUTER SKILLS
Proficient in MS Word, Lotus Notes, Excel and various CTMS
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