Regulatory Affs Specialist I | CAR T
About City of Hope
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.
Requisition ID: 13861
Job Title: Regulatory Affairs Specialist I | CAR T
Position Summary and Key Responsibilities:
The Regulatory Affairs Specialist I will be responsible for preparing clinical protocol amendments, deviations, exemptions and continuations for review and submission. As well as supporting 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 investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), as well as Manufacturing, Quality Control, and Quality Assurance staff. In addition, individual will assist with regulatory maintenance and review of Investigator site files to include Form FDA 1572â€™s, IRB approvals, training documentation, etc. to ensure regulatory compliance.
Additionally, specialist will be responsible for logistic coordination such as coordinating related meetings, action items, product tracking and planning activities.
Under the direction of the Associate Director of the T Cell Therapeutics Research Laboratory (TCTRL) or Regulatory Operations Manager, will provide assistance and support to Principal Investigators, for timely and accurate submissions related to clinical protocols under their auspice. This may also 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 TCTRL Associate Director or Regulator Operations Manager or designee, to physicians and principal investigators, IBC, 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:
- Requires a Bachelorâ€™s degree in a scientific discipline or equivalent
- Minimum Experience:A minimum of 0 to 2 years of related experience.
- Preferred Courses/Training:Training/Certification in Regulatory Affairs or laboratory experience in relevant scientific field
- Preferred Experience:Regulatory Affairs, Clinical Trials Management or relevant scientific field.
- Skills/Abilities:Must possess excellent written/editorial, interpersonal, verbal communications and computer literacy skills. Communicate technical information in a clear, concise manner.
- Compose letters/memorandums; coordinate meetings; proofread documents, research information; prepare reports; manage projects use computer packages; use team-building skills
- Excellent written/editorial communication and organization skills; Foster and promote a positive image.
- Software:Microsoft Word, Microsoft Excel, Windows, Access, PowerPoint.
- Machines/Equipment:Calculator, Computer peripheral equipment, personal computer, photocopier.
- Working / Environmental Conditions:Expose 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 up to 20 lbs.).Frequent walking.
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.
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