ERT

Technical Quality Assurance Specialist

US-PA-Philadelphia
Shift
Mon-Friday, 8:30-5pm
Type
Regular Full-Time

Overview

ABOUT ERT

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.

 

ERT’s Philadelphia office has an opening for a Technical Quality Assurance Specialist. This person will institute and perform quality programs to ensure the training, precision, and accuracy of the data generated by ERT with regard to technology and skilled staff.

 

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  1. Performs monthly inter-observer over reads of ECG/Holter data.  Generate monthly reports summarizing results and assure appropriate corrective action is implemented. 
  2. Supports maintenance of a database of all over read programs, the results, and corrective action summaries. 
  3. Provides monthly and where applicable quarterly, semi-annual, and annual reports of all over read programs and study specific reports as required. 
  4. Provides monthly reports to the Quality Assurance and Cardiac Safety Operations Management with the over read status and results. Completes the routine summarization and reporting of ECG/Holter Action Plan metrics.
  5. Performs quality reviews to ensure the data and processes implemented by ERT are compliant with applicable regulations, guidelines, and internal procedures.  This includes quality reviews of primary study documentation including raw data, reports, data listings, and FDA XML file deliverables as well as the establishment and training of ECG measurement criteria and alert ranges.
  6. Organization of the monthly inter- and intra-variability over reads. This includes identifying and providing the ECG and Holter data to be analyzed to the Cardiac Safety Specialists, assuring completion and reporting of results. 

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Assist in the implement training programs for Cardiac Safety Specialists at all levels, as required.
  2. Assist in the implementation of ongoing assessment/certification programs for Cardiac Safety Specialists.
  3. Assist in the organization and maintenance of the Cardiologist Over Read Programs. This includes the submission of all ECGs/Holters for over read, evaluation of results, and quarterly reporting to the Quality Assurance and Cardiac Safety Operations Management in addition to follow up for all corrective actions.
  4. Provide operations with ongoing support in the evaluation and resolution of quality problems through the evaluation and analysis of quality program statistics.

 

 

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

 

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Qualifications

 

  1. College Degree in Health/Life Sciences
  2. 2-3 years ECG/Holter measurement experience
  3. Excellent organizational and communication skills
  4. Detail oriented
  5. Proficiency in Microsoft Word and Microsoft Excel

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 

 

 

 

 

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