Clinical Research Regulatory Specialist

Clinical Research Coordinator (eRegulatory Implementation Lead)

University of Southern California (USC)

Founded in 1880, the University of Southern California (USC) is one of the world's leading private research universities and the largest private employer in the City of Los Angeles. As a member of the Trojan Family, you will join a dynamic community of faculty, staff, students, and researchers dedicated to advancing knowledge, innovation, and excellence in education, research, and patient care.

Position Summary

The Department is seeking an experienced and highly motivated Clinical Research Regulatory Specialist  to support both clinical trial operations and the implementation of a transformative electronic regulatory (eRegulatory) platform. Reporting to the Assistant Director of Clinical Research Operations, this individual will serve as the primary liaison between research teams, institutional leadership, and technology partners in the development, implementation, and optimization of the electronic Investigator Site File (eISF/eBinder) system.

This role offers a unique opportunity to lead digital transformation initiatives while ensuring regulatory compliance, operational excellence, and successful adoption of innovative clinical research technologies. The ideal candidate will combine strong clinical research experience with a passion for process improvement, training, and change management.

Key Responsibilities:

eRegulatory System Implementation and Development

• Partner with departmental leadership to support the strategic implementation, configuration, and expansion of the selected eRegulatory platform.

• Design, map, and validate electronic binder structures, folder hierarchies, and user access permissions in alignment with industry standards and trial reference models.

• Collaborate with internal stakeholders and system implementation teams to configure workflows that support activities such as remote monitoring, electronic signatures, and eConsent processes.

• Standardize and centralize commonly used site documentation (e.g., CVs, medical licenses, FDA Form 1572s, training records) to improve efficiency and reduce duplication across studies.

• Identify opportunities to streamline regulatory processes and enhance operational effectiveness through technology-enabled solutions.

Training, User Support, and Leadership Collaboration

• Serve as the departmental eRegulatory Super User and subject matter expert.

• Assist leadership in developing and maintaining standard operating procedures (SOPs), work instructions, and quick-reference guides related to eRegulatory processes.

• Provide training and ongoing support to Principal Investigators (PIs), sub-investigators, study coordinators, and research staff on system navigation, electronic signatures, document management, and task workflows.

• Facilitate onboarding sessions for new users and monitor adoption metrics to identify training needs and continuous improvement opportunities.

• Act as a resource for troubleshooting system issues and escalating concerns when appropriate.

Clinical Operations and Regulatory Compliance

• Support Principal Investigators and study teams with study start-up, maintenance, continuing reviews, and close-out activities within the eRegulatory environment.

• Manage the electronic filing and maintenance of essential regulatory documents, including IRB approvals, protocol amendments, safety reports, and study correspondence, ensuring inspection readiness and audit-compliant documentation.

• Serve as a primary point of contact for clinical research associates (CRAs), monitors, and auditors, facilitating remote review of study records and electronic source documentation.

• Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor requirements across all assigned studies.

• Promote a culture of quality, compliance, and continuous process improvement within the research program.

Minimum Qualifications:

Education

• Bachelor's degree in Life Sciences, Health Administration, Public Health, or a related field.

• Equivalent combinations of education and experience may be considered in lieu of a degree.

Experience

• Minimum of three (3) years of experience as a Clinical Research Coordinator, Regulatory Specialist, or related clinical research professional.

• Experience supporting multiple clinical trials and regulatory requirements in an academic medical center, hospital, or research setting preferred.