Clinical Trials Regulatory Specialist 2 (Remote Opportunity)

Stanford University; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Stanford University’s Clinical Research Hub (CRH) seeks a mission-driven Clinical Trials Regulatory Specialist 2 to ensure regulatory compliance and effective collaboration across clinical operations and sponsors.

The role involves interface with study teams, IRBs, FDA, and other authorities, requiring strong communication, integrity, and project-management skills. The position supports flexible onsite, hybrid, or remote work arrangements to advance global clinical research initiatives.

Qualifications

• Experience with regulatory submissions.
• Knowledge of Good Clinical Practices (GCP) and SOPs.
• Ability to collaborate with sponsors, investigators, and study teams.

Responsibilities

• Ensure compliance with GCP and SOPs.
• Collaborate with clinical operations, QA, education, and business development managers.

Skills

Regulatory compliance

Communication

Project management

Interpersonal skills

Job description

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!