The Manager, Clinical & Human Research Protections provides administrative and operational oversight for the City of Hope’s Clinical Research Protections (CRP) Committees: Cancer Protocol Review and Monitoring Committee (CPRMC), Protocol Review and Monitoring Committee (PRMC), and the Institutional Review Board (IRB), referred to collectively below as the “Committees”. The Manager ensures compliance with all external regulations, best practices and internal policies directly related to the Committees’ reviews and serves as a liaison between the Committee members and the City of Hope Research Community. Through close collaboration with each Committee’s physician leaders and members, and Analyst support teams, the Manager maintains an efficient and effective operating framework for the day-to-day operations of the Committees and their support team.
The Manager is responsible for overseeing the activities of the Research Protocol Analysts (RPAs) as they relate to protecting human subjects in research and the NCI Cancer Center Support Grant Protocol Review Monitoring System. The manager oversees and advises the RPAs in their effort to coordinate protocol pre-reviews, meeting agendas and Committee reviews and subsequent meeting minutes. The Manager is responsible for continuously reviewing and improving RPAs’ work product and serves as a subject matter expert on the day-to-day operations of the Clinical Research Protections Office.
The Manager is expected to collaborate closely with other City of Hope Managers and Directors to ensure a timely and rigorous review of protocols consistent with the expectations of the NCI Cancer Center Support Grant and requirements from Federal research oversight entities including the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This may include the offices within Research Operations, Regulatory Support Services (RSS), Clinical Trials Office (CTO), Office for Protocol Development (OPD), Office of IND Development & Regulatory Affairs (OIDRA), and the Cancer Center Administration.
Key Responsibilities include:
Leads the day to day operations of the CRP office and CPRMC/PRMC/IRB Committees, proactively identifying and implementing solutions to improve efficiency, effectiveness, and timeliness of office processes to reduce time to final approval while maintaining rigorous scientific, ethical and regulatory compliant reviews.
Takes leadership responsibility for prioritizing and acting on urgent requests or projects submitted by the CRP Director, RPU senior leaders, PIs and other City of Hope departments and discusses prioritization and work execution issues with Director when necessary.
Use quantitative and qualitative metrics, along with various forms of stakeholder feedback and benchmarks to identify operational performance improvement opportunities and implement sustainable process improvements. Participates in ongoing clinical research performance improvement initiatives.
Coordinates and works with other departmental managers to ensure effective interaction with other RPU departments. Advises PIs and their staff of the regulatory and Committee requirements that must be fulfilled in order for a study to be conducted at COH. Work collaboratively with the Senior Director, Research Protections, CRP Director, Committee Chairs, Directors and Managers within Research Operations and other Institutional leaders to evaluate and remediate compliance issues. Assures that all relevant information is communicated to Committee Chairpersons, PIs, the IRB, CTO, and other relevant groups.
Ensures all protocol review related information is accurately maintained electronically in an audit-ready fashion. Prior to an external audit, locates the appropriate protocol file(s); determines adequacy for the audit; is present during the audit to answer any questions and to assist the auditor in clarifying issues, locating correspondence and other protocol-related documents that may not be easily located or apparent at time of the audit. Represents the IRB office in a professional and appropriate manner during these external reviews of IRB protocol files.
In conjunction with the Director, continuously assesses the iRIS system for effective receipt, logging, tracking, pre-review of submissions, review of PI responses and other related protocol business. Reviews iRIS and proposes changes, clarifications and improvements to the application and oversees implementation of sustainable change to impacted persons/groups.
Maintains expert working knowledge of regulations and policies governing human subjects research at City of Hope, including but not limited to OHRP, FDA, NIH, NCI, CCSG, GCP, etc. Keep abreast of new internal and external developments related to the regulatory oversight of clinical research.
Assists with CRP intranet maintenance.
Leads in managing the routine work product of Research Protocol Analysts and Senior Research Protocol Analysts; mentors and promotes their professional development and growth. Supervises and provides direction for Research Protocol Analysts including hiring and performance evaluations.
Reviews, verifies, and assures proper RPA content knowledge and analysis of Committee members’ protocol reviews and ensures that Committee actions are appropriately integrated into the minutes and action notices to be addressed by the PI to assure that all concerns, rationales, and technical questions of the Committees are accurately represented and concisely communicated. Continuously reviews the adequacy of communication and RPA assessments of the protocols and associated consent forms for accuracy and consistency.
Responsible for onboarding new hires.
Organize, facilitate and attend all CPRMC/PRMC/IRB meetings and work with Committee members and staff to ensure efficient and effective meeting conduct and accurate meeting minutes. After each Committee meeting, ensure that action notices are completed and signed, meeting minutes are prepared and distributed, and follow-up items are completed and tracked.
Responsible for facilitating regular CPRMC/PRMC/IRB Executive Committee meetings and providing regular updates on the respective committees’ performances and progress.
Significantly contributes to the CCSG Competitive Grant Renewal submission, the annual progress reports for the PRMS section as well as material for Cancer Center External Advisory Committee Meetings. Responsible for developing materials and support the NCI site visits including the protocol packet submissions, Data Table 4 curation, and the Institutional List curation.
Continuously assess Committee practices for efficient and effective alignment with federal and state and local regulations, accreditation standards, and best practices related to scientific review.
Coordinates reviews and approval requirements with the Clinical Trials Finance Office for clinical trials agreements, the Radiation Safety Committee (RSC), the Institutional Biosafety Committee (IBC) (for gene transfer studies), and other groups as needed, making sure that these additional department/committee approvals have been secured prior to study activation.
Interacts with the PI and/or PI staff to advise them of the appropriateness of their applications and communicates any requirements to be addressed to secure approval of the study.
Serves as the lead author and maintains and ensures implementation of the CPRMC, PRMC, and IRB Charters, Manuals, guidelines, work instructions and Policies and Procedures to ensure consistency with Institutional, OHRP, FDA, NIH, NCI, etc. requirements and updates.
Aids in the assessment and impact of new and existing office policies and procedures on the overall work flow and the procedures required for appropriate implementation in relation to requirements that must be imposed upon investigators and their support staff in conjunction with the Director.
Develops and maintains daily operational procedures for the efficient processing of research proposals, including proper and effective receipt, logging, routine tracking, handling of protocol status inquiries, pre-review of submissions, issuing of action notices, and review of responses and related protocol business.
Ensures regulatory compliance with Institutional and Individual Authorization Agreements including IRB Authorization Agreements with external partners.
Work with the Director to develop and deliver trainings/in-services for the City of Hope research community on regulatory requirements, review mechanisms and Board functions, website location of related forms and their appropriate uses, etc.
Attend regional and/or national conferences to keep abreast of current issues and trends with regard to regulatory concerns and issues, and represent COH in a professional manner.
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:
Must have a Bachelor's degree;
Must have seven or more years of experience in research regulatory administration/management, preferably in a NCI-designated Comprehensive Cancer Center or academic medical center;
Must demonstrate leadership, professionalism, process improvement, personnel management, problem solving and customer service skills;
Must have working knowledge of Good Clinical Practice (GCP) standards and clinical research regulatory requirements from the FDA, NIH, OHRP, and study sponsors;
Must demonstrate ability to work with clinicians and scientists, preferably in an academic environment;
Must have effective interpersonal and writing skills to expertly communicate complex information with PIs, administrative and research personnel;
Must have analytical skills to support review of research protocols and ability to demonstrate attention to detail pertaining to consent form review against established criteria in conformance with state and federal regulations;
Must have ability to work as a team member in an office where there are numerous deadlines and time-sensitive issues requiring judgment and flexibility;
Must have experience in research environment or as a Clinical Research Associate;
Must have excellent oral/written communication and organizational skills.
Preferred education experience and skills:
Scientific Master’s degree;
Three or more years of supervisory experience;
Experience in managing clinical trials in academic research setting;
Knowledge of NCI guidelines for Cancer Center Protocol Review and Monitoring (PRMS) and Data and Safety Monitoring (DSM) including site visit protocols and documentation requirements;
Certified IRB Professional (CIP) upon hire or within three years of employment.
Internal Number: 10002555
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.