About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.
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Position Summary
Clinical Research Protections provides administrative, regulatory and operational support to the Data and Safety Monitoring Committee (DSMC). Research Protocol Analysts manage a portfolio of human research protocols from initial submission through the protocol's life cycle ensuring that protocol are reviewed appropriately by relevant committees. Accordingly, Research Protocol Analysts are familiar with the human subject protection regulations set forth at 45 CFR 46 and 21 CFR Parts 50, 56, 312, 600 and 812 and other federal guidance, as well as the cancer center support grant requirements. Research Protocol Analysts also serve as resources familiar with appropriate regulations and requirements to COH researchers and committee members. Research Protocol Analysts have frequent interactions with Principal Investigators (PIs), study team members, committee members, and other departments involved in the review, approval and oversight of research conducted at City of Hope facilities or by its employees or agents.
Key Responsibilities include:
Protocol Management:
Research Protocol Analysts are expected to shepherd protocols through the DSMC review process to achieve a timely outcome that is compliant with applicable regulations. Analysts are responsible for managing review of new protocols, amendments, progress reports, monitoring reports, audits, SAEs, deviations, unanticipated problems and other reportable events.
- Conduct pre reviews of all submissions in anticipation of DSMC review, including but not limited to completeness of the submission and compliance with DSMC policies as well as federal requirements for approval.
- Work with the Meeting Coordinator to ensure timely review by convened committee/expedited reviewer and appropriate reviewers have been assigned based on expertise.
- Prepare committee minutes documenting the determinations required by the CCSG and/or applicable federal regulations.
- Prepare action notices to the Investigators summarizing the committee review outcome and conditions for approval.
- Monitor the timeliness of investigator responses to committee conditions and PMT progress reporting and escalate as necessary to ensure timely approval. Pre-review investigator responses to ensure completeness and that they satisfy the conditions before routing for final approval. Liaise with investigators and study team members to address any outstanding issues.
Committee Meetings:
- Prepare materials for committee meetings for assigned protocol submissions ensuring completeness and supplement the packets with relevant reports, e.g., SAE and deviations reports.
- For submissions raising novel regulatory questions, provide committee members with relevant reference and guidance.
- During the meetings, have sufficient familiarity with the assigned protocol and submission to address committee member questions on past reviews determinations and overall history.
Internal and External Audits
- As requested, assist in preparing materials for internal and external audits and accreditations
- Ensure assigned protocols are audit ready with appropriate documentation is filed, current and compliant with internal and external requirements.
Quality Improvement Initiatives
- Identify areas for process improvement and efficiencies that also support regulatory compliance.
- Keep up to date with current regulations and guidances
- 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.
- Participate in educational sessions
- Bachelor's degree
- At least 2 years of experience in the academic/clinical research review setting
- Experience in review and processing of research protocols in an academic research setting
- To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.
- Posting Date: Nov 29, 2021
- Job Field: Clinical Research
- Employee Status: Regular
- Shift: Day Job