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HonorHealth - Regulatory Specialist Resume Example

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Chloe Torres
XXXX X XXXXXXXXX XXXXXX XXX XXXXXXXX XXXXX, Mesa, AZ 85215
XXXXXXXXXXXXXXXXXXXXXX
Ph: XXXXX XXXXXXXX
Professional Summary

Accomplished and energetic clinical regulatory specialist with a solid history of achievement in managing multiple studies in a organized, comprehensive manner. Managed over 40 studies at two sites over a six year period with no assistance.  Accepts responsibility and takes ownership of duties assigned to me.  Works well with others, respecting and welcoming diverse ideas and innovative ways to best accomplish a common goal. Strong desire to work in a cohesive, collaborative environment.

Skills

Over 30 years of experience in medical environments Able to work independently, self directed, strong work ethic

Over ten consecutive years of research experience Currently managing regulatory oversight for over 45 projects, including cardiovascular, bariatric, trauma, and emergency medicine studies

Strong belief in teamwork, values, positive relationships and respect in the workplace 

Experience
Regulatory Specialist Aug 2008Present HonorHealth Scottsdale, AZ

Prepare all new study start up documents for sponsor and IRB submission.

Prepare and submit documents to the IRB for review and approval of amendments, continuing review, administrative letters, advertisements, patient materials, etc.

Maintain regulatory binders for completeness through life span of study.  Insure that binders are in organized, comprehensive order for monitoring visits and/or audits

Assist research staff in development of regulatory documents, including informed consents

Develop and maintain tracking tools  to manage deadlines and timelines in the submission of time sensitive documents

Assist study team with training in Good Clinical Practices, Protection of Human Subjects and other compliance requirements.


Administrative Assistant/ Regulatory Specialist May 2004Aug 2008 Scottsdale Cardiovascular Research Institute Scottsdale, AZ

Prepared and submitted documents to sponsors and a large number of IRBs.

Managed all written documents pertaining to study trials

Responsible for organization and maintenance of study binders

Tracked sponsor payments and patient stipends

Managed physicians schedule for meetings, speaking engagements and travel

Accounts Manager Mar 2001Apr 2004 Scottsdale Eye Surgery Center Scottsdale, AZ

Handled accounts payable and bookkeeping duties for surgery center

Managed payroll for three sites

Managed accounts receivable staff of six people for three sites

Worked closely with accountant and outside vendors

Education
Pre-Nursing Umpqua Community College Roseburg, OR
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Resume Details

This is a real resume for a Regulatory Specialist in Mesa, Arizona with experience working for such companies as Honorhealth, Scottsdale Cardiovascular Research Institute, Scottsdale Eye Surgery Center. This is one of the hundreds of Regulatory Specialist resumes available on our site for free. Use these resumes as templates to get help creating the best Regulatory Specialist resume.

Previous Companies:

  • HonorHealth
  • Scottsdale Cardiovascular Research Institute
  • Scottsdale Eye Surgery Center

Previous Job Positions:

  • Regulatory Specialist
  • Administrative Assistant
  • Accounts Manager

Schools:

  • Umpqua Community College

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