The Clinical Research Hub (CRH) is part of the Stanford Department of Medicine. CRH is seeking a mission-driven Clinical Trials Regulatory Specialist 2. In this role, you will collaborate with a high-performing team of clinical operations staff and medical experts. Your responsibilities will include ensuring compliance with Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs), while working closely with clinical operations, finance, quality assurance, education, and business…
development managers. You will engage with company sponsors, clinical research organizations, Stanford investigators and their study teams, the Stanford Institutional Review Board (IRB), other external IRBs, the FDA, and various regulatory authorities, as well as any other entities that contribute to clinical research at our institution.
The ideal candidate will possess exceptional interpersonal, communication, and diplomacy skills, along with the ability to manage multiple projects effectively. Previous experience in regulatory submissions and direct collaboration with clinical experts and industry sponsors is required. A strong commitment to integrity, excellence, and continuous improvement is essential. This position offers flexibility in work arrangements, including onsite, hybrid, or remote options.
At CRH, we are dedicated to finding team members who are passionate about their work, adaptable, and enthusiastic about achieving results. We prioritize equipping our staff to perform their roles efficiently, facilitating skill development and opportunities for growth within the organization. We support our team in maintaining a healthy work-life balance and encourage applicants who want to make a significant impact through global-reaching clinical research to apply!
Responsibilities
Core Duties:
- 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.
Minimum Education and Experience
Bachelor's degree and five years of related experience or a combination of education and relevant experience.
Knowledge, Skills and Abilities
- Excellent communication and organizational skills and superb attention to detail.
- Experience with MS Office products and database applications required.
- Excellent inter-personal skills and customer service focus is required.
- Experience in clinical research management and oversight, including project management in a dynamic research setting.
- Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
- Experience in developing and implementing training/education.
- Demonstrated ability to manage multiple projects and staff under varying time constraints.
- Strong writing skills.
Organization
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