Regulatory Affairs Specialist II - CAR T
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 nationâ€™s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Job Title: Regulatory Affairs Specialist II - CAR T
Position Summary and Key Responsibilities:
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.
- 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.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Requires a Bachelorâ€™s degree in a scientific discipline or equivalent.
- Minimum Experience:A minimum of 2 to 5 years of regulatory affairs experience with Bachelors or 0 to 2 years of regulatory affairs experience with Masters.
- Preferred Courses/Training:
- Basic Biology (Molecular and Cellular).
- Chemistry (Inorganic, Organic and Biochemistry).
- GMP facility operations.
- Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance.
- Preferred Certification/Licensure:RAPS, SOCRA or ACRP Certification.
- Preferred Experience: Regulatory Affairs, Clinical Trials Management, or relevant scientific field.
- Skills/Abilities:Foster and promote a positive image and professional appearance.
- Autonomous and self-directed.
- Demonstrated laboratory skills.
- Knowledgeable about State and Federal regulatory requirements.
- Excellent writing skills required, including grammar and spelling. Able to correctly use technical terms and abbreviations.
- Excellent organizational skills.
- Attend to details and be methodical.
- Maintain record keeping systems.
- Document activities (filing, archiving, compiling).
- Prepare reports.
- Proof read documents.
- Ability to work under tight deadlines and prioritize tasks.
- Required: Excellent written and oral communication skills, team player, self-motivated, excellent personal hygiene, practice good judgment in all professional activities. Ability to analyze data and compose reports. Ability to set and model professional work standards.
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.