Research Protocol Analyst – Data and Safety Monitoring Committee
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Job Description
Research Protocol Analyst providing regulatory and operational support for human research protocols at City of Hope. Ensuring compliance with human subject protection regulations and managing protocol reviews.
Responsibilities:
- Shepherd protocols through the DSMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations.
- Be responsible for managing the review of new protocols, amendments, progress reports, monitoring reports, audits, serious adverse events (SAEs), deviations, unanticipated problems and other reportable events.
- Prepare materials for committee meetings for assigned protocol submissions ensuring completeness and supplement the packets with relevant reports, e.g., SAE and deviations reports.
- As requested, assist in preparing materials for internal and external audits and accreditations and ensure assigned protocols are ready with appropriate documentation is filed, current and compliant with internal and external requirements.
- Identify areas for process improvement and efficiencies that also support regulatory compliance.
- Participate as requested in quality improvement initiatives which may include but are not limited to policy and/or procedure development or updates, electronic form revision in iRIS, workflow updates and report and dashboard enhancements to support daily operations.
Requirements:
- Bachelor’s Degree in life sciences, information technology, business administration, or related fields. Higher degree preferred.
- 3 years of experience in systems and database management
- Experience with sponsored research management / research operations software systems.
- Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), or Certified Clinical Research Coordinator (CCRC) is preferred but not required.
- Strongly preferred prior use of a grant management system
- Experience in sponsored research, academic, research environment or Comprehensive Cancer Center preferred.
Benefits:
- Comprehensive Benefits
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