Regulatory Affairs Specialist II
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.