Research Compliance Manager

$29.00 - $32.00 hourly
  • Employnet
  • Palo Alto, CA, USA
  • Jul 11, 2019
Full time Biotech Education Health Care / Medical Research Science

Job Description

 

Oversee and facilitate the coordination of the protocol review process in accordance with the University's Human Research Protection Program.

CORE DUTIES*:

  • Develop, implement, and manage efficient procedures to facilitate the processing of human research protocols in accordance with, federal, accreditation, and state policies and procedures.
  • Perform review of complex research protocols, including identifying problems and issues in the submission application and contacting the investigator orally or in writing to request additional materials.
  • Plan and coordinate monthly IRB review and follow-up activities.
  • Serve as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
  • Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
  • Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities.

* - Other duties may also be assigned


Education & Experience:

  • Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.

Knowledge, Skills and Abilities:

  • Comprehensive knowledge of regulatory information regarding the use of human participation in research and teaching.
  • Demonstrated understanding of the principles of human research protection standards.
  • Strong knowledge of grants and contracts function.
  • In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
  • Demonstrated strong verbal and written communication skills.
  • Knowledge of human subjects and federal and state policies and procedures.
  • Knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.

 

Certifications and Licenses:

Institutional Review Board professional certification desirable.

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