Clinical Trial Document Specialist - Biotech Resume Search
Clinical Trial Document Specialist - Biotech Resume Search
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Clinical Trial/Document Specialist Resume


Desired Industry: Biotech SpiderID: 60402
Desired Job Location: Napa, California Date Posted: 5/10/2012
Type of Position: Full-Time Permanent Availability Date: May 28, 2012
Desired Wage: Negotiable
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Other Willing to Relocate: Undecided


Objective:
A position in the Biotech/Pharma industry
to utilize proven abilities in clinical
trial start-up activities, management of
clinical trial documents.


Experience:
SANTEN INC., Napa, CA
2008 – 2011 Clinical Research Specialist
2006 – 2008 Clinical Research Assistant
2001 – 2006 Executive Assistant

•Assisted with clinical trial tasks from
start-up through study report
publication.
•Managed clinical trial documents,
tracked, audited and reconciled
discrepancies.
•Performed clinical trial data entry
using various systems.
•Created and used checklists to assess
TMF completeness and quality.
•Assisted with submission of essential
documents to Regulatory agencies.
•Collaborated with project team members
to resolve TMF and eTMF deficiencies.
•Created and implemented a TMF
electronic file system (eTMF).
•Created electronic filing procedures,
processes and guidelines.
•Created PDF interactive forms with
signature fields.
•Interacted with clinical trial
Investigator site staff.
•Provided training, demonstrations and
support to department staff.
•Registered clinical trial protocols on
clinicaltrials.gov.
•Conducted site monitoring and site
close-out visits and completed
documentation.
•Coordinated planning and assisted with
set up of Investigator Meetings.
•Assisted Clinical Trial Manager and
Associates with daily study functions.
•Maintained and managed various database
systems.
•Reviewed clinical data (CRFs) and
assisted with data corrections
•Generated and processed contracts,
payments, and various trial reports.
•Managed and procured clinical trial
equipment, developed equipment
instructions.
•Created spreadsheet with formulas to
track and manage data.
•Supported department Executive,
managers and clinical trial staff.
•Generated and submitted expense
reports, calendar appointments, and
travel.
•Organized and maintained study files
and study materials.
•Assisted receptionist with front desk
support.


Education:
A.A., Business, Heald Business College,
San Jose, CA


Skills:
Microsoft Word, PowerPoint, Excel,
Access, Visio, Microsoft Outlook


Additional Information:
ADDITIONAL TRAINING, EDUCATION
Monitoring Clinical Drug Studies
Drug Development and FDA Regulations
Monitoring Phase I Clinical Trials
Introduction to Clinical Data Management
NextDocs Trial Master File Seminar
Santen Ophthalmology Training


Reference:
Available upon request.


Candidate Contact Information:
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