Regulatory Affairs Specialist II
ID: 7101704 (Ref.No. 10016570)
Posted: June 9, 2022
Application Deadline: Open Until Filled
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 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 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.
The Regulatory Affairs Specialist will be responsible for all aspects of clinical research regulatory compliance, including document preparation, submission, and management, for a specified portfolio of clinical trials conducted in the Department of Translational Research & Cellular Therapeutics within the Arthur Riggs Diabetes & Metabolism Research Institute. This includes preparing for review and submission, portions of 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 Research Project & Regulatory Manager. In preparation of these filings, individual will be responsible for interacting with internal personnel to include Research Project & Regulatory Manager, Department Director, AR-DMRI Principal Investigators and their staff, clinical research nurses and coordinators, Manufacturing, Quality Control, and Quality Assurance staff, and others. In addition, individual will assist with regulatory review of Investigator site files to include Form FDA 1572’s, IRB approvals, etc. to ensure regulatory compliance.
Key Responsibilities include:
- Will coordinate the preparation and timely submission of regulatory documents to the City of Hope Institutional Review Board (IRB), Protocol Review and Monitoring Committee (PRMC), Data Safety and Monitoring Board (DSMB), other internal and external regulatory oversight committees, national cooperative groups, industrial clinical research sponsors, and Contract Research Organizations (CROs) as necessary to meet all internal and external regulatory compliance standards. Responsibilities include, but are not limited to:
- Initial review of research protocols and informed consent documents,
- Preparation and submission of protocol amendments, continuations, adverse events, and document addendums
- Assistance with FDA submissions in collaboration with other City of Hope departments and Regulatory Affairs Offices.
- Will aid and support to Principal Investigators and staff within Office of IND Development and Regulatory Affairs (OIDRA), for timely and accurate submissions for IND under their auspice. This may include, but is not limited to, preparation, review, and compilation of IND Annual Reports; protocol review for Protocol Amendments; review of documentation for Informational Amendments, and review of Safety Reports.
- Assist in gathering information from Study Coordinators, Physicians, other staff, and study sponsors as needed for the submission of regulatory documents.
- Will maintain master regulatory files/binders. This will include reviewing site documentation for accuracy and completeness.
- Assists with the preparation of departmental standard operating procedures (SOPs).
- Ensure compliance to applicable regulatory and quality policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.
- Assists Research Project & Regulatory Manager with aspects of the research trials regulatory process to include:
- Prepare routine protocol status reports for the Investigators, research staff and internal/external regulatory committees as needed.
- Oversee and maintain documentation of correspondence to and from the IRB and other regulatory committees.
- Assist AR-DMRI researchers in study design, consent form creation and compliance with IRB requirements.
- Communicate to AR-DMRI staff relevant aspects of the regulatory processes and requirements for protocol development and conduct of research trials.
- Understand and advise AR-DMRI staff about institutional requirements for protocol development and conduct of research trials.
- Provides guidance, under supervision of Research Project & Regulatory Manager or designee and other COH regulatory officials, to physicians and principal investigators, CPRMC, PRMC, DSMC, and IRB in the interpretation of applicable regulations and guidelines, to include but not limited to GCP, GLP, ICH, FDA, and NIH OBA guidelines.
- Participate in clinical trial adherence evaluations and compliance audits.
- May assist in facilitating regulatory agency inspections.
- Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in the field of expertise.
- Performs other related duties as assigned or requested.
- Is self-motivated in organizing and following through on assigned projects.
- Ensures work environment is organized and functions efficiently.
- Attends and participates in meetings as required.
- Tolerates flexible work hours to achieve critical deadlines.
Basic education, experience and skills required for consideration:
- Bachelor’s degree in a scientific discipline or equivalent. Experience may substitute for minimum education requirements.
- A minimum of 5-7 years related experience with a Bachelor’s or 3-6 years with a Masters, or 2-5 years with a PhD, and demonstrated working knowledge of scientific principles.
- Up to date familiarity with regulations pertaining to INDs involving CDER, CBER and NIH-OBA activities, including experience as an auditor, quality control coordinator, or compliance officer.
Preferred education, experience and skills required for consideration:
- Graduate Level Degree in Regulatory Affairs or related field.
- Certification in Regulatory Affairs preferred.
- Must possess excellent written/editorial, interpersonal, verbal communications, and computer literacy skills.
- Must communicate technical information in a clear, concise manner.
- Ability to monitor and train other employees.
- Ability to master content across all clinical research areas.
- Previous supervisory experience preferred.
- Preferably has experience with Adobe Framemaker.
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.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.