Research Protocol Analyst

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.

Position Summary

Clinical Research Protections provides administrative, regulatory and operational support to the Cancer Protocol Review and Monitoring Committee (CPRMC), the Protocol Review and Monitoring Committee (PRMC), and the Institutional Review Board (IRB). 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.

Essential Functions:

• Protocol Management. Research Protocol Analysts are expected to shepherd protocols through the C/PRMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations. Analysts are responsible for managing new protocols, amendments, continuing reviews, deviations, unanticipated problems and other reportable events.
  • Conduct pre reviews of all submissions in anticipation of C/PRMC and IRB review, including but not limited to completeness of the submission and compliance with C/PRMC and IRB 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 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
• External IRB
  • For protocols under the jurisdiction of the external central IRBs, including, but not limited to NCI CIRB, NMDP sIRB, conduct a QC on the informed consent to ensure consistent and appropriate incorporation of the local boilerplate language.
  • Assist in annual worksheet development and/or supplemental materials as requested.
  • Assist as necessary, in providing information on external institutions when asked to cede review
• 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

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. Performs other related duties as assigned or requested.

Basic education, experience and skills required for consideration:

• Bachelor's degree.
• At least 2 years of experience in the academic/clinical research review setting.

Preferred experience and certification/licensure required for consideration:

• Certified IRB Professional (CIP).
• Experience in review and processing of research protocols in an academic research setting.

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

Software and machine/equipment:

• Microsoft Office; Outlook Excel; iMedRIS (Committee management software); Forte's OnCore (clinical research management system).
• Personal computer, copy machine, telephone system and fax.

Working / Environmental Conditions:

• Office setting atmosphere and environment
• Subject to many interruptions and need to reprioritize work
• Occasionally subjected to extended hours
• Exposed to material of a confidential nature on a daily basis
• Pressure due to deadline requirements

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. #LI-GD

• Posting Date: Sep 15, 2021
• Job Field: Clinical Research
• Employee Status: Regular
• Shift: Day Job