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REGULATORY AFFAIRS SPECIALIST II - 10035512
Duarte, CACity of Hope is an independent biomedical research and treatment center 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 wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional 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.
Pay Rate: $40.82 - $63.27 per hour
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
A Regulatory Affairs Specialist II position is available in the Diamond Research Laboratory. You will assist and support internal and external PIs, for timely and accurate submissions related to clinical protocols under their jurisdiction. This may also include preparation, review, and compilation of Investigational New Drug Application (IND) Annual Reports; protocol review for protocol amendments along with review of documentation for informational amendments, and review of safety documentation. In preparation for these submissions, you 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. You will also assist with regulatory maintenance, amendments/approvals (IRB, IBC, and IACUC), training documentation, etc. to ensure regulatory compliance.
As a successful candidate, you will:
- Lead in the design and development of clinical protocols, consent forms, SOPs, and other documents required by the project.
- Ensure compliance with protocol, regulatory and overall clinical and quality objectives.
- Compose, edit or review laboratory SOPs, and review/revise manufacturing and quality testing SOPs.
- Write pre-clinical and clinical documents, handle submissions for iRIS and respond to regulatory authorities.
- Communicate critical information related to project timelines and core project teams.
- Act independently to determine methods and procedures of new projects.
Your qualifications should include:
- Bachelors degree in a scientific discipline or equivalent with a Masters degree preferred.
- 2-5 years of regulatory affairs experience with a Bachelors or 0-2 years of regulatory affairs experience with a Masters
- Preferred experience within regulatory affairs, clinical trials management or relevant scientific field
- RAPS, SOCRA or ACRP Certification is preferred but not required
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, please CLICK HERE.