About City of Hope

City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope’s specialized cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

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

Responsible for clinical protocols under their auspice including supporting the regulatory affairs activity relating to City of Hope Immunotherapy investigator-initiated INDs, from initial filing to Phase I/II clinical trials. The position will assist in the development of clinical protocols, clinical trial start-up timelines, preparing meeting agendas and following-up on action items, coordinating priorities and able to adjust to newly assigned priorities set by the Associate Director of the T Cell Therapeutics Research Laboratory (TCTRL).

This position will also assist in Investigational New Drug Application (IND) filings to include but not limited to: annual reports, protocol amendments, informational amendments, safety reports, and sections of initial filings as requested by the section or project lead. In preparation of these filings, individual will be responsible for interacting with internal personnel to include investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), as well as Manufacturing, Quality Control, and Quality Assurance staff.

Additionally, this position will require supporting the workload, activities and training of an assigned Regulatory Specialist I.

Key Responsibilities include:

· Conducts training to CRAs of specific clinical activities related to Immunotherapy projects following Good Clinical Practices (GCP), E6 Guidelines of clinical monitoring, SAE reporting, and SOP monitoring. May train associates in regulatory submission process and clinical activities.

· Leads in the design and development of clinical protocols, case report forms, consent forms, training and other documents required by the project.

· Ensures compliance with protocol, regulatory and overall clinical objectives.

· Composes edits or reviews clinical and regulatory SOPs, designs forms and labels, and reviews or revising manufacturing SOPs.

· Contributes to the development of the clinical budget based on the clinical study design, and related expenses for the manufacture of clinical product.

· Writes clinical document and annual report submissions for iRIS and responds to regulatory authorities.

· Communicate critical information related to project timelines and core project teams.

· Reviews, plans and tracks resources and timelines to ensure that projects are met.

· Ensures coordination of timelines and priorities and communication of project expectations and deliverables with Clinical and Regulatory Affairs (e.g., Manufacturing, Research & Development).

· Acts independently to determine methods and procedures of new projects.

· Provides guidance to the PI, manufacturing, associates and support staff to achieve goals for regulatory timelines and strategy.

· Participates in diligence activities.

· Provides technical insights to other departments as part of cross-functional project teams. Maintains awareness of and expertise in ICH, FDA and NIH-OBA guidelines topics.

Preferred education experience and skills:

· RAPS, SOCRA or ACRP Certification

· Regulatory Affairs, Clinical Trials Management, or relevant scientific field

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.

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