Regulatory Specialist; Hybrid

Regulatory Specialist (Hybrid Opportunity) at Stanford University summary:

The Regulatory Specialist supports clinical trials by preparing regulatory submissions, managing documentation, and ensuring compliance with FDA, IRB, and other regulatory bodies. The role involves acting as a liaison between investigators and regulatory agencies, providing guidance, training, and managing regulatory strategies and staff. This hybrid position requires expertise in clinical research regulations, protocol development, and project management within a biomedical research environment.

The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Division is seeking a Clinical Trials Regulatory Specialist II position to support a very active clinical trials faculty. The position will anticipate and generate reports and prepare documents for submission as required by the IRB, FDA, OSP and APB requirements, including annual reports, and IND safety reports. The position will author and submit new applications according to CFR 21 Part 312 including Investigator New Drug (IND) applications, revisions, amendments, and Informed Consent documents in support of BMT-CT clinical research and coordinate with the Stanford Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures.

The position will gather, evaluate, organize and manage information from a variety of sources to draft/finalize biomedical research protocols during the development phase, including draft content and formatting to meet requirements of Stanford, Institutional Review Board (IRB), United States Food and Drug Administration (FDA), Office of Science Policy (OSP) and APB (Biosafety Committee).

The BMT-CT program at Stanford performs autologous and allogeneic transplantations for over 400 patients each year. The program has been very successful with a history of limited morbidity rates and acute mortality that is well below most published reports. In addition to a successful clinical practice, our program researchers are translating their discoveries into new therapies, advancing the efficacy of hematopoietic cell transplantation for patients worldwide.

This is a hybrid eligible position.

Duties include:

• Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required.

• Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development.

• Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.

• Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.

• Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.

• Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.

• May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams.

• May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.

• May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.

DESIRED QUALIFICATIONS:

• Experience with Protocol/IND writing.

• Experience with BMT-CT disease focus.

EDUCATION &…