Research Protocol Analyst (Remote)

About City of Hope

City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.

City of Hope’s commitment to Diversity, Equity and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work - and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.

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.

Key Responsibilities include:

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.

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 education, experience and skills:

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

Additional Information:

• The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

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.