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Clinical Research Quality Assurance Specialist

Job Attributes

Job Id:

30727

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Clinical Solutions is seeking a motivated Clinical Research Quality Assurance Specialist in Bethesda, MD to support an established research firm supporting both commercial and government clients with ongoing clinical research trials. The QA Specialist will be responsible for QA Training, Audits, and CAPA Investigations related to assigned clinical research studies.


Responsibilities for the Clinical Research Quality Assurance Specialist:

·       Ensure assigned clinical trial projects meet client and federal regulatory compliance requirements

·       Support and maintain upkeep of Quality Management System and train site research staff on proper procedures, compliance and regulatory requirements

·       Maintain the QA training program, document control and Corrective Action Preventative Action (CAPA) program

·       Obtain and develop metrics to identify areas of improvement and potential CAPA investigations

·       Lead all CAPA investigations and develop reports based on findings for all assigned studies

·       Review and maintain QA plans and lead process improvement initiatives

·       Prepare, analyze, and update Project Specific Standard Operating Procedures (SOP) for assigned studies

·       Manage and support clinical sites, suppliers, and vendors to ensure quality assurance compliance

·       Conduct external audits of clinical sites including document management and quality management systems to ensure compliance and identify areas for process improvement

·       Verify site compliance utilizing SOPs and other applicable regulations (GCP, GDP, GXP)

·       Lead and support internal audits of trial documentation/SOPs and ensure compliance with Good Clinical Practice (GCP) standards and client protocols


Requirements for the Clinical Research Quality Assurance Specialist: 

·       2+ years of Quality Assurance experience working within a clinical research organization and supporting clinical trials (GCP/GDP/GXP)

·       Advanced knowledge of medical terminology

·       Certified Quality Auditor (CQA) certification preferred

·       Bachelors required in science-related field, Master’s Degree preferred


Compensation for the Clinical Research Quality Assurance Specialist:

·       Salary range: $60,000 – $90,000 based on meeting of qualifications

·       Benefits: Health, Dental, & Vision insurance and 401K

 

Please send all qualified resumes to: bnoell@pipercompanies.com


Keywords:

Good Clinical Practice, GCP, Good Manufacturing Practice, GMP, Good laboratory Practice, GLP, GXP, GDP, Good Documentation Practice, Quality Assurance, QA, Quality Management, Quality Auditor, CQA, Clinical Research Organization, CRO, Quality Management System, QMS, quality audit, Bethesda, regulatory,  FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, SOP, Quality Management Program, QMP, Analytical Tools, SOP, Standard Operating Procedure, medical terminology

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New Search

Job Id:

30727

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions