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18 days old

Clinical Research Quality Management Specialist

Gateway Institute for Brain Research
Fort Lauderdale, Florida 33314
  • Job Type
    Employee
  • Job Status
    Full Time

The Gateway Institute for Brain Research is actively seeking a Clinical Research Quality Management Specialist to support GCP and FDA regulatory compliance for Parkinson Disease clinical research projects. This is an exciting opportunity for a motivated, experienced, clinical research compliance professional to get in on the ground floor of a research institute utilizing in vivo, in vitro, in silico, and clinical research to develop new treatments for neurodegenerative disorders. This position is located at the Gateway Institute for Research office in the Center for Collaborative Research on the Nova Southeastern University campus in Davie, Fl.  


RESPONSIBILITIES:

The primary responsibility of this role is to establish, implement, and conduct quality management procedures to ensure sponsor and investigator site clinical trial operations are conducted in compliance with GCP and 21 CFR 50, 56, and 312. The Clinical Research Quality Management Specialist works closely with the Clinical Trials Manager, Director of Quality Management, Director of Information Systems, and General Counsel to accomplish tasks. 


Duties include: 


  • Develop, update, and maintain SOPs related to clinical research operations compliance.

  • Assist the risk manager in identifying key risk indicators and developing quality management processes, risk assessments, and risk mitigation strategies.

  • Work with cross functional teams to ensure appropriate delegation of tasks and completion of risk mitigation strategies. 

  • Assist with the validation, implementation, and maintenance of electronic systems (i.e. eTMF, EDC). 

  • Train applicable staff on SOPs and monitor compliance.

  • Provide periodic reports to department leaders and escalate issues as necessary. 

  • Perform monitoring and auditing activities for sponsor and clinical site operations.

  • Provide training on research compliance to new staff members and perform periodic continuing education compliance training for all applicable staff. 

  • Perform vendor validation and audits of CROs, other third-party vendors, and electronic systems. 

  • Work with research and clinical operations to review regulatory documents as requested.

  • Other duties as assigned.

Requirements

  • Bachelor’s degree required

  • Sponsor-level FDA compliance experience required

  • Strong understanding of ICH GCP guidelines and 21 CFR 50, 56, and 312

  • Must be a self-starter and have a strong ability to work independently 

  • CCRP, CCRC, or monitoring/auditing certification highly preferred

  • At least 6 years of experience in clinical research in an FDA-regulated environment. At least 4 years in a compliance role. 

  • Experience with electronic systems (eTMF, eISF, etc.) a plus

  • Some travel may be required

Categories

Posted: 2019-11-27 Expires: 2019-12-27

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Clinical Research Quality Management Specialist

Gateway Institute for Brain Research
Fort Lauderdale, Florida 33314

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