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 employees pay is based on the following criteria: work experience, qualifications, and work location.

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