Objective:
 

Looking for medical writing or drug safety work from home


Work Desired:Contract or Direct
Citizenship:US Citizen
Resident Of:State: Hew Hampshire - Area Code: 603
Willing To Relocate:Yes
Posted By Candidate:07/26/09
Experience:More than 3 years of work-experience
Technical Skills:, Project Management
Work Experience:
Cathryn A. Faulring, RD
4 Waterview Circle  Litchfield  NH  03052 
 [Send email to request phone number] 24-4508   


EDUCATION     Framingham State College, Framingham, MA			May 2000
	Bachelor of Science Degree in Food and Nutrition, minor in Biology			
	Concentration:  Coordinated Program in Dietetics

SUMMARY OF EXPERIENCE
     Therapeutic areas of experience include respiratory, central nervous system
(CNS), oncology, cardiovascular, neurology, X-ray and DXA scans.  Experience
working on Phase III, Phase IV and post marketing studies.  Experience with
Clinical Databases including Oracle Clinical, ClinTrial, Oracle AERS, Oracle
Discoverer and EDC (electronic data capture).  Experience as a Serious adverse
event lead on two studies.  Experience in working in Drug Safety and
Pharmacovigilance including study start up activities and presentations. 

WORK EXPERIENCE
   Sepracor, Inc. 		           Marlborough, MA (Drug Safety Associate)		 10/2005
       
•	Data collection and processing for SAE Clinical trial reporting in Oracle AERS
(SAE/adverse event information via phone, email from consumers and Health Care
Providers).  
•	Coding of SAE/AE terms using MEDRA coding and COSTART coding.  
•	SOP/WPI Development
•	Experience in study start up activities including Investigator meeting
presentations

  Boston Scientific	           Natick, MA (Clinical Data Specialist)		
10/2004-10/2005
•	Clinical data review, data discrepancy listings and data clarifications on
intermediate complexity projects using Electronic Data Capture.
•	Document, resolve, and integrate data queries while interacting with project
team, Biostatistics, Clinical, database development, and clinical sites.
•	Involved in database lock.
•	User Acceptance testing and validation of the database. 
•	Data Management status report generation.

  Synarc                                        Maynard, MA  (Clinical Data
Manager)   		  6/2004-9/2004 
•	Clinical data review, data transfers and data clarifications on intermediate
complexity projects.
•	Liaison between Client/Sites for data discrepancies.
•	Involved in SOP development.
•	Analysis and transfer of SAS datasets of X-ray and DXA scans.
•	Issuing reports using SAS programs.   
	
    PAREXEL International        Waltham, MA  (Clinical Data Manager)   		 
2000- 2003
•	Clinical data review/data clarifications on intermediate complexity projects
using Oracle Clinical and Clintrial.
•	Document, resolve, and integrate data queries while interacting with project
team/teams.
•	Review of data discrepancy listings, with query documentation and resolution.
•	Liaison between Client/Site/Safety for associated Serious Adverse Event
Reconciliation.
•	Serious adverse event lead for two studies.  
•	Involved in QC audits and locking of the database.

     Catholic Medical Center        Manchester, NH (Dietary Supervisor)		  
1997- 2000 
•	Collected and corrected menus for modified diets.
•	Supervised cafeteria workers on a tray line.
•	Updated diet orders using a computerized order/entry system.

    
 
United States Coast Guard							1992 - 1996
•	Maintenance and sanitation aboard a 270' Coast Guard Cutter.
•	Administrative duties at a Coast Guard communications station.

SUPERVISED PRACTICE EXPERIENCES

Clinical Experience               New England Rehabilitation Hospital, Woburn,
MA	          Spring 2000
•	Taught a weekly class on Heart Healthy diets and counseled patients on
modified diets.
•	Assumed staff relief responsibilities for the rehab/cardiac floors.

Foodservice Management     Sebastian's Catering, Fidelity, Marlborough, MA      
               Fall 1999
•	Developed a food safety training program and instructed workers in three
separate facilities.
•	Utilized management theory and human relations skills to assume
responsibilities of Foodservice Manager during staff relief.

Community Nutrition	      Lynn WIC Community Center, Lynn, MA		            Fall
1999
•	Organized and presented nutrition education classes for target audiences of
varied income. 
•	Provided nutrition education to groups to promote healthy eating.


AFFILIATIONS
American Dietetic Association /New Hampshire Dietetic Association

COMPUTER SKILLS
EDC, Oracle AERS, Clintrial 3.3, Oracle Clinical, Basic SQL/SAS, Microsoft Word,
Excel, Power Point, Food Processor, Computrition, MasterCook, MasterClips, basic
computer graphic design, Avaya Agent.
Clinical Trials experience: Respiratory, CNS, Oncology, Cardiovascular, DXA
scans, and X-ray imaging on Phase III, Phase IV studies.


 

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