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Highmark Health Quality Assurance Coordinator / Research in Pittsburgh, Pennsylvania

Company :

Allegheny Health Network

Job Description :

GENERAL OVERVIEW:

The Quality Assurance (QA) Coordinator ensures that all processes contributing to the performance of a clinical trial are conducted properly. The QA Coordinator is charged with serving as the subject matter expert across all AHN Institutes on lawful, ethical research practice and will perform proactive, routine monitoring of research studies, regulatory documentation, and clinical data. When necessary, the QA Coordinator will partner with AHN Research Institute leadership to implement process improvement initiatives, staff education, and corrective action plans.

ESSENTIAL RESPONSIBILITIES:

  • Assesses research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidance though implementation of a risk-based monitoring program (40%)

  • Interfaces between multiple AHN Institutes to evaluate, develop, and deploy standard operating procedures (SOPs) (20%)

  • Collaborates with AHN Institute research teams to educate staff on research best practices (20%)

  • Works with research staff to prepare and verify responses to the queries and corrective action plans generated from monitoring of research protocols (10%)

  • Compares research data with source documentation for accuracy and integrity (10%)

QUALIFICATIONS:

Minimum

  • Master’s degree in Research Practice, Natural Sciences, Health Administration, or Allied Health

  • 1 - 3 years clinical trials monitoring

  • 3 - 5 years development and or oversight of investigator-initiated and pharma-sponsored clinical trials

  • 1 - 3 years extensive knowledge of regulatory/research documentation submission and maintenance

  • 1 - 3 years electronic Data Capture (EDC) and research database management

  • 1 - 3 years Standard Operating Procedure (SOP) development

  • Certification in Healthcare Research Compliance (CHRC) - Health Care Compliance Association (HCCA) required within 12 months of hire

Preferred

  • Bachelor’s degree in Nursing

  • 1 - 3 years development of research quality assurance programs and research staff education

  • Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SoCRA)

  • Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP)

  • Certified Clinical Research Associate (CCRA) - Association of Clinical Research Professionals (ACRP)

As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.


Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability.

EEO is The Law

Equal Opportunity Employer Minorities/Women/ProtectedVeterans/Disabled/Sexual Orientation/Gender Identity ( http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf )

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For accommodation requests, please contact HR Services Online at HRServices@highmarkhealth.org

Req ID: J150678

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