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Work Desired:Full Time - Permanent
Citizenship:US Citizen
Resident Of:State: Arizona - Area Code: 480
Willing To Relocate:No
Posted By Candidate:1+ Year Ago
Experience:More than 3 years of work-experience
Technical Skills:, LAN/Networking, Project Management
Work Experience:
Fanny Sparrow
Phone:  [Send email to request phone number] 32.7485

17846 North 93rd Way
Scottsdale, AZ 85255

Regulatory Specialist, Radiant Research, Chandler/Scottsdale, AZ
Dec 08 - Present
 * Prepare regulatory documents and IRB submissions for all enrolling protocols
 * Track status of pending protocols for IRB review
 * Submit initial Investigator and any revisions throughout the course of the
study
 * Submit all Informed Consent Revisions and protocol amendments for IRB
approval
 * Oversee tracking and reporting of all Serious Adverse Events to IRB and
Sponsor
 * Ensure sponsor safety letters are submitted to the IRB
 * Track, prepare and submit interim reports and final summaries to the IRB
describing study activity
 * Oversee preparation of all closed study files for archiving in long term
storage
 * Cross-train in site accounting procedures as needed
Recruitment Specialist, Radiant Research, Chandler, AZ
Nov 06 - Present
 * Management of recruitment activities on all enrolling protocols
 * Managed all recruiting study material submission to IRB
 * Management of advertisement development and placement with media service
groups. Ensure advertisement is complete and correct
 * Management of advertisement funds
 * Updated medical histories and status of all subjects in database
 * Reviewed medical charts and screen sheets (from call center) for potential
study participants
 * Organized and coordinate community outreach
 * Point person for project managed studies
 * Participated in off-site investigator's meetings, initiation meetings and
protocol discussion and training
Quality Assurance Editor, Signet Claim Solutions, Melville, NY (telecommute)
May 06 - Dec 06
 * Reviewed/Edited Independent Medical Reports and Peer Review Files for
adherence to State regulations, structural and content errors, appropriateness of
specialty referral and accuracy of claimant and billing information
Clinical Study Manager, MDS Pharma Services, Phoenix, AZ
May 05 - May 06
 * Managed clinical trials and clinic staff
 * Interpreted and assured adherence to study protocols
 * Collected, analyzed and reported clinical study data
 * Planned, organized and lead client initiation meetings; monitored visits and
audits
 * Planned and executed study participant orientation meetings
 * Ensured compliance, quality, and profitability of clinical studies
 * Reviewed clinical laboratory test results, medical history information and
informed consent documents
 * Reviewed and approved staffing for each study
 * Created case report forms for each study
 * Established and maintained communication with client concerning study
progress and developments including reports of adverse events
 * Participated in manager's meetings; worked on strategies to increase quality
and productivity

Admissions Specialist, MDS Pharma Services, Phoenix, AZ
Mar 04 - May 05
 * Planned and executed pharmaceutical study participant selection
 * Developed custom participant questionnaires based on study inclusion and
exclusion criteria
 * Interviewed potential study participants
 * Managed communication of information between Admission personnel, Private
Investigators, Study Managers and the Quality Assurance department
 * Prepared written Spanish to English translations of medical history
information
 * Coordinated payment of participant stipends at study completion
 * Performed study information meetings with potential study participants to
obtain proper consent

Credit Analyst, American Express, Inc., Phoenix, AZ
Nov 02 - Aug 03
 * Serviced, collected & controlled customer accounts
 * Ensured maximum recovery on delinquent accounts
 * Inbound and outbound telephone contact with Small Business Owners and
Corporate Card Clients

Training Coordination Supervisor, Concentra/NHR, Inc., Woodbury, NY
Jun 01 - Sept 02
 * Trained staff in customer service and QA of Independent Medical Exams and
File Review reports
 * Developed training materials and documentation
 * Evaluated and documented trainee performance and training effectiveness
 * Organized and performed new employee orientations and office walk-throughs
 * Interviewed candidates for employment
 * Developed staff cross-training rotation program
 * Assisted in the development of a national corporate training program
Sr. Account Representative, National Healthcare Resources, Inc., Woodbury, NY
Jul 99 - Mar 01
 * Facilitated the entire IME process through continuous interaction with claim
representatives, physicians, attorneys and claimants
 * Generated bills for claimant "no shows" and sent to claims adjusters
 * QA'd Peer Reviewed files for appropriateness of specialty referral and
accuracy of claimant and billing information; Furnished carrier with fee summary
and specialists report
Physician Mgmt Representative, National Healthcare Resources, Inc., Woodbury,
NY
Dec 98 - Jul 99
 * Nationwide physician recruitment
 * Contacted physician offices to schedule IME appointments and request IME
reports and addendum's
 * Logged appointments made, claimant shows and no shows, and reports received
into electronic database
 * Supplied physicians with claimant medical records upon request
 * Resolved IME scheduling delays

EDUCATION

Clinical Research Professional Certification (CCRP)
Society of Clinical Research Associates, November 2008
Bachelor of Business Administration in International Business
Hofstra University, Hempstead, NY - August 98
**Fluent in English and Spanish **

 

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