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Job Details

Regulatory Affairs Specialist II CAR T

Company name
City of Hope

Location
Duarte, CA

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Profile

About City of Hope City of Hope, an innovativebiomedical 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. Requisition13025 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.
Essential Functions: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 Bachelor 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. Associated topics:diet, dietary,
disease, health, healthcare, medical, microbiological,
microbiology, pharmacometrics, vaccine

Company info

City of Hope
Website : http://www.cityofhope.org

Company Profile
The City of Hope story began in 1913, when a group of volunteers, spurred by compassion to help those afflicted with tuberculosis, established the Jewish Consumptive Relief Association (JCRA) and raised money to start a free, nonsectarian tuberculosis sanatorium. After several fundraisers, the JCRA put a down payment on 10 acres of sun-soaked land in Duarte, where they would establish the Los Angeles Sanatorium a year later. The original sanatorium consisted of two canvas cottages. So was launched a century-long journey that would place City of Hope at the forefront of the nation’s leading medical and research institutions.

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