About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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
Laboratory Research Protections provides administrative, regulatory and operational support to the Institutional Animal Care and Use Committee (IACUC) and the Stem Cell Research Oversight (SCRO). Research Protocol Analysts manage a portfolio of animal research protocols and stem cell research protocols from initial submission through the protocol's life cycle ensuring that protocols are reviewed appropriately by relevant committees. Accordingly, Research Protocol Analysts are familiar with federal and state regulations and requirements for the use of animals and pluripotent stem cells in research. 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 IACUC and SCRO review processes to achieve a timely outcome that is compliant with applicable regulations. Analysts are responsible for managing new protocols, amendments, renewals, continuing reviews, unanticipated problems and other reportable events.
- Conduct pre reviews of all submissions in anticipation of IACUC and SCRO review, including but not limited to completeness of the submission and compliance with IACUC and SCRO policies as well as federal requirements for approval.
- Assist with verifying that mandated training requirements have been met for individuals listed on IACUC and SCRO protocols.
- Ensure timely review by appropriate review path and ensure appropriate reviewers have been assigned based on expertise
- Prepare committee minutes documenting the committee determinations
- 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 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.
- Monitor the timeliness of committee member review and re-assign as needed to ensure timely approval.
- Coordinate IACUC animal facility or laboratory inspections as part of the protocol review process.
- Conduct congruence analysis to ensure that proposed activities are consistent with the associated funding application(s).
- Committee Meetings:
- Schedule and coordinate committee meetings and ensure quorum is met
- Prepare materials for committee meetings for assigned protocol submissions ensuring completeness .
- Ensure agendas for committee meetings are complete and circulated
- 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 review 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 and appropriate documentation is filed, current and compliant with internal and external requirements.
- As requested, assist in scheduling IACUC semi-annual facility inspections. Communicate with Center for Comparative Medicine and investigators to ensure inspection follow-up items and findings are documented and appropriately addressed according to deadlines.
- Committee Management:
- Assist with preparing new committee member appointment packages
- Assist with onboarding and training new committee members
- Assist with conducting and tracking continuing education for committee members
- 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
- As requested, maintain updated intranet sites
- Bachelor's degree.
- At least 2 years of experience in the academic/basic research review setting
Preferred experience and certification/licensure required for consideration:
- Experience in review and processing of research protocols in an academic research setting.
- Certified Professional in IACUC Administration (CPIA).
Skills/Abilities:
- Knowledge of complex federal and state regulations involving the use of human and/or animal subjects in research
- Analytical skills to review research protocols for completeness.
- Effective interpersonal skills to deal with complex, sensitive and confidential material with PIs and administrative and research personnel.
- Effective writing ability to document and summarize salient points and results of meeting proceedings. Ability to communicate the same in writing and verbally to PIs.
- Ability to work as a team member in an office where there are numerous deadlines and time-sensitive issues requiring judgment and flexibility.
- Working knowledge of relational data bases for management of research protocols.
- Ability to pay attention to details involving protocols documents.
- Excellent organizational and time management skills
- Present a positive professional image; demonstrating service orientation.
Additional Information:
- 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.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
- Posting Date: Dec 22, 2021
- Job Field: Research
- Employee Status: Regular
- Shift: Day Job