Regulatory Affairs Specialist I | 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 nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Job Title: Regulatory Affairs Specialist I| CAR T
Position Summary and Key Responsibilities:
The Regulatory Affairs Specialist I will be responsible for 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 section or project lead. In preparation of these filings, individual will be responsible for interacting with internal personnel to include Manufacturing, Quality Control, and Quality Assurance staff, as well as investigators and their 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.
- Under the direction of either the Director of OIDRA or his/her designee, will provide assistance and support to Principal Investigators, 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.
- Will participate in reviewing investigator regulatory files. 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.
- Provides guidance, under supervision of Director of OIDRA or designee, 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.
- 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.
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:
- A minimum of 3 to 5 years related experience with Bachelors or 0 to 2 years with a Masters, or 0 to 2 years with a PhD, and demonstrated working knowledge of scientific principles.
- Minimum experience:3 to 4 years of related experience.
- Requirements, other:Must possess excellent written/editorial, interpersonal, verbal communications and computer literacy skills. Communicate technical information in a clear, concise manner.
- Preferred Education:Regulatory Affairs courses at university level or higher.
- Preferred Courses/Training:Formal Graduate training in Regulatory Affairs.
- Preferred Field of Expertise:Regulatory Affairs or relevant scientific field.
- Aptitude:Compose letters/memorandums; coordinate meetings; proofread documents, research information; prepare reports; manage projects use computer packages; use team-building skills.
- Software:Microsoft Word, Microsoft Excel, Windows, Access
- Machines/Equip:Calculator, Computer peripheral equipment, personal computer, photocopier.
- Working / Environmental Conditions:Exposure to material of a confidential nature on a regular basis. Occasional pressure due to multiple calls and inquires. Occasional pressure due to deadline requirements. Subject to many interruptions. Subject to regularly changing priorities and work assignments. Tobacco free Campus.
- Physical Demands:Light physical effort (lift/carry to 15lbs). Occasionally lifts supplies and equipment. Occasionally reaching, stooping, bending, kneeling. Some standing/walking
- Communication:Excellent written/editorial communication and organization skills; Foster and promote a positive image.
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.