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Clinical Research Quality Assurance Consultant

Job Attributes

Job Id:

21667

Job Category:

Clinical & Life Sciences

Job Location:

Silver Spring, MD  20910

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Life Sciences is currently seeking a Clinical Research Quality Assurance Consultant in Silver Spring, MD to support quality oversight of clinical trials for a major biopharmaceutical organization. The Clinical Research Quality Assurance Consultant will lead overall support to site start-up, data management systems, documentation and regulatory compliance for a niche medical device trial branch of the organization.

 Responsibilities of the Clinical Research Quality Assurance Consultant

  • Own, develop and manage clinical trial auditing program to ensure both domestic and international regulatory compliance
  • Manage oversite of CRO (contract research organizations) to ensure compliance from a data, regulatory, quality system, and agency inspection perspective
  • Review CRO (contract research organization), bioanalytical laboratories, regulatory, and other audits that have been completed by third-party agencies to ensure quality and accuracy of overall findings
  • Develop, write, and edit standard operating procedures (SOPs) by providing previous knowledge towards inherited SOPs to tailor towards specific clinical trials
  • Support and collaborate with the Director of Regulatory Affairs in providing audit, regulatory, and corrective action (CAPA)

 Qualifications of the Clinical Research Quality Assurance Consultant

  • 4+ years of experience within clinical research quality assurance
  • Understanding and experience with audits, regulatory affairs, IRB (institutional review board), clinical research, contract research organizations (CROs)
  • Experience with medical device clinical research trials
  • Bachelor of Science in Biology, Chemistry, Chemical Engineering, Biochemistry, or related life science

Compensation for the Clinical Research Quality Assurance Consultant

  • Salary: up to $150,000 commensurate with experience
  • Full Benefits: Medical, Dental, Vision, 401k

 

Please send all qualified resumes to Michael Epstein at mepstein@pipercompanies.com

 

Keywords: clinical research quality assurance, quality assurance, CRO, contract research organization, irb, institutional review board, audits, standard operating procedures, SOP, transplants, clinical trials, CRA, clinical research associate, quality database, quality systems management, manager, consultant, site start-up, site initiation, feasibility, close-out, TMF, trial master file

 

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New Search

Job Id:

21667

Job Category:

Clinical & Life Sciences

Job Location:

Silver Spring, MD  20910

Security Clearance:

No Clearance

Business Unit:

Piper Companies