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Medical Device Clinical Research

Location:
Addison, Texas, United States
Salary:
45000
Posted:
March 20, 2011

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Isis Wanderer

**** ******** *****

Little Elm, TX 75068

(972) ***-****

obxfml@r.postjobfree.com

Objective: To obtain a position as a clinical research coordinator with a leading research organization.

Relocation: Open to relocation throughout the United States.

Summary of Qualifications:

• Over 6 years experience as a aesthetic surgical procedure product specialist, primarily ultrasound surgical equipment

• Excellent ability to recruit physicians, identify clinical investigators and maintain relationships

• Perform all product specialist responsibilities in accordance with Avamed guidelines

• Report adverse product effects in accordance with company SOP’s

Professional Training:

140 Hour Clinical Research Associate Training Program conducted by Medical Research Management, Inc., an accredited provider through ACPE.

“Fundamentals of Clinical Research” February 2011

Part 1: Comprehensive e-learning with a 7 Chapter Textbook covering:

• FDA History, Overview of Medicinal Product Development, Human Subject Protections & GCP (Device and Drug Studies), HIPAA’s Research Provision, ICH GCP E 6/E2a, Clinical Trial Development, Clinical Trial Management – Sponsor & Investigator Perspective, Monitoring Obligation and Method.

Part 2: Two weeks Hands-On Monitoring covering:

• Perform monitoring activities applying the MRM Step Monitoring Method, a systematic approach used to increase monitoring accuracy and efficiency. Monitoring of six study subjects and three Investigator Study Files across two therapeutic areas. Each case has an increase in GCP non-compliance.

• Resolving GCP related issues via Corrective Action and Preventative Action (CAPA) to secure compliance. The foundation to writing professional and effective monitoring reports to document the securing of GCP compliance. Comparison on the differences between drug/biologic versus medical device studies.

• Criteria for Course Completion: MRM Monitoring Competency Examination minimum of 80% & Fundamentals Regulatory Exam minimum 70%.

• MRM is a proctor and has adopted the ACRP (Association of Clinical Research Professionals) Clinical Research Core Knowledge Assessment (CKA) Test.

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Employment:

Sound Surgical Technologies, Louisville, CO. Manufacturer of ultrasonic surgical equipment. Account Manager for Texas and surrounding states,

December 2002 – April 2009

• Built relationships and networked with physicians, surgical staff, nursing staff and hospital administrators

• Maintained more than 150 physician relationships following sale of equipment

• Served as a product specialist with extensive knowledge of cosmetic surgical procedures

• Arranged physician proctorships

• Clinical product training and presentations on use of ultrasonic surgical equipment both in and outside of the operating room

• Coordinated training events under Avamed guidelines

• Arranged shipment and installation of equipment including required documentation of equipment placement and training administered

• Documented and reported medical device adverse events to post market surveillance

Northwest Airlines, St Paul, MN.

Flight Attendant and International Purser March 1997 – December 2002

• Followed FAA regulations and documentation requirements including regular updates of policies to my company assigned flight attendant manual

• Responsible for comfort and safety of passengers

• Timely and efficient boarding and deplaning

• Management of in-flight medical and non-medical emergencies

Education:

Amberton University, Dallas, TX B.S. Human Relations and Business, April 2010

Computer Skills:

Proficient in Word, Excel, and PowerPoint

Professional Memberships:

ACRP member, 2011

ACRP Central Texas Chapter member 2011

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