Clinical Research Manager

HEATHER A. ORR, BS, CCRC

CURRICULUM VITAE

Home address: **** ******** ****

Wesley Chapel, FL 33544

Home phone: (813) 352-4881E-mail: ******@*****.***

EDUCATION AND TRAINING

April 2011 Anticipated Graduation University of Florida

Master of Science: Pharmaceutical Outcomes and Policy

2001-2003 Slippery Rock University, Slippery Rock, PA

Bachelor of Health Science: Community Health Focus

1999-2001 Community College of Allegheny County, Pittsburgh, PA

General Studies

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WORK EXPERIENCE

4/10-present Phase 1 Clinical Research Coordinator/ Moffitt Cancer Center

Tampa, FL

Coordination duties include scheduling of oncology research participant visits and

procedures, confirming eligibility of patients for trials, consenting patients,

completion of source document and case report form data, close monitoring

of Adverse Events, and working closely with clinical research associates.

All duties are performed in compliance with FDA regulations, ICH, and

GCP guidelines.

8/05- 3/10 Clinical Research Manager/ Women’s Care Florida

Tampa, FL

Management responsibilities include supervision of research staff, administration of all

clinical trials, negotiation of study budgets with sponsors, and tracking study

payments. Coordination duties include completion and submission of

regulatory documents, internal auditing, protocol adherence, quality data

collection, SAE/AE reports, and drug accountability. All duties are

performed in compliance with FDA regulations, ICH, GCP guidelines and

company SOP’s.

5/04-7/05 Clinical Research Assistant/ University of Pittsburgh

Magee-Women’s Hospital of UPMC

November 29, 2010

Pittsburgh, PA

Responsibilities included coordination of a Women’s Health NIH funded

research trial as well as utilization of clinical skills. Study coordination

duties included Research interviewing, scheduling of patient visits, case

report form preparation, data entry, subject retention, quality management

and drug accountability. Clinical duties included phlebotomy, vital signs,

exam room assisting and specimen processing.

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ADDITIONAL TRAINING AND CERTIFICATION

2008 CPR Infant, Child, Adult Certification

2008 Certified Clinical Research Coordinator (ACRP-current)

2008 IATA Certification

2006 Strategies for Successful Study Coordination Workshop

2006 OSHA Training

2005 Good Clinical Practices Certification

2004 University of Pittsburgh, Research Practice Fundamentals:

Research Integrity

2004 University of Pittsburgh, Research Practice Fundamentals: Human Subjects

2004 Phlebotomy Certification

PROFESSIONAL MEMBERSHIPS

2010 Association of Clinical Research Professionals (ACRP)

Clinical Research Trial Experience and References Available Upon Request

November 29, 2010

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