Clinical Research Coordinator (eRegulatory Implementation Lead)

University of Southern California (USC)

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.

Technical Skills

• Proficiency with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and electronic Investigator Site Files (eISF).
• Experience with Florence eBinders, Complion, or similar eRegulatory platforms strongly preferred.
• Demonstrated ability to learn and support new technologies and digital workflows.

Knowledge and Competencies

• Strong understanding of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
• Excellent organizational, project management, and problem-solving skills.
• Exceptional attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Strong interpersonal and communication skills with the ability to build consensus, influence adoption, and train diverse stakeholder groups.
• Commitment to delivering high-quality service and advancing operational excellence.

Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.

This position is remote. Work hours and remote days may be subject to change depending on business needs.

The annual range for this position is $75,968.95 - $101,364.43 . When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education: Bachelor's degree

Addtional Education Requirements Combined experience/education as substitute for minimum education
Minimum Experience: 2 years
Addtional Experience Requirements Combined experience/education as substitute for minimum work experience
Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype).
Preferred Education: Bachelor's degree

Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector
Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research.

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