Clinical Trials Regulatory Specialist 2 (Remote Opportunity)

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!

Core Duties:

• Prepare regulatory submissions (such as IRB and IND/IDE) andapplications and annual reports. Complete all related regulatorydocuments and maintain correspondence and telephone contacts withregulatory agencies. Submit annual reports and updates asrequired.

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

• Develop, deliver and manage tools to facilitate education andtraining, prepare written materials to communicate with researchcommunity including presentations, one-on-one training and orientationsessions.

• Oversee and maintain regulatory documentation, safety reportingprocedures and audit safety reports to ensure they are appropriatelyhandled.

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

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

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

• May hire, orient, and provide ongoing training and directsupervision to regulatory staff. Assign work tasks, provide dailysupervision of these tasks; provide verbal and written evaluation ofwork performance.

• May contribute to establishing and developing Standard OperatingProcedures for the conduct of clinical research. Ensure SOPs arecompliant with international, federal, state, and local regulations, andconsistent with the objectives of the clinical researchoperation.

Minimum Education andExperience

Bachelor’s degree and five years of related experience or acombination of education and relevant experience.

Knowledge, Skills and Abilities:

• Excellent communication and organizational skills and superbattention to detail.

• Experience with MS Office products and database applicationsrequired.

• Excellent inter-personal skills and customer service focus isrequired.

• Experience in clinical research management and oversight,including project management in a dynamic research setting.

• Strong knowledge of regulatory affairs, including FDAregulations, IRB review and approval process, and Good ClinicalPractice.

• Experience in developing and implementingtraining/education.

• Demonstrated ability to manage multiple projects and staff undervarying time constraints.

• Strong writing skills.