Clinical Research Regulatory Specialist

Clinical Research Regulatory Specialist - Operations

The University of Southern California (USC), founded in 1880, 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 vibrant community of faculty, staff, students, and researchers dedicated to advancing knowledge, innovation, and excellence in education, research, and patient care.

Position Summary:

Reporting to the Assistant Director of Clinical Research Operations, the Regulatory Affairs Specialist is responsible for overseeing and managing the regulatory aspects of clinical research studies conducted through the Clinical Trials Office. This role independently manages complex, multi-phase clinical research protocols from study start-up through closeout, ensuring compliance with all applicable federal, state, local, sponsor, and institutional regulations governing human subjects research.

The Regulatory Affairs Specialist serves as the primary regulatory resource for non-cancer clinical trials and is responsible for coordinating, preparing, and maintaining regulatory documentation for industry-sponsored, federally funded, and investigator-initiated studies. The incumbent will lead regulatory-related study meetings, maintain investigator site files, ensure the timely collection and maintenance of essential documents, and support study teams in meeting all regulatory requirements throughout the lifecycle of a clinical trial.

This position plays a key role in developing and implementing processes that promote regulatory compliance, data integrity, and adherence to Good Clinical Practice (GCP), institutional standard operating procedures (SOPs), and University policies.

Key Responsibilities:

• Manage all regulatory activities for assigned clinical research studies from study initiation through closeout.

• Prepare, submit, and track regulatory submissions, including Initial Applications, Amendments, Continuing Reviews, and Reportable Events to the Institutional Review Board (IRB), Food and Drug Administration (FDA), sponsors, and other regulatory agencies as required.

• Ensure timely reporting of regulatory submissions, adverse events, protocol deviations, and other reportable events in accordance with applicable regulations and study requirements.

• Maintain accurate and audit-ready investigator site files and essential regulatory documentation.

• Collaborate with Principal Investigators, study coordinators, sponsors, and research staff to ensure ongoing regulatory compliance.

• Serve as a liaison with regulatory and compliance entities, including the IRB, FDA, sponsor representatives, monitors, and external agencies.

• Participate in and lead study-related regulatory meetings, providing guidance on regulatory requirements and compliance considerations.

• Maintain accurate study information within the Clinical Trial Management System (OnCore) and electronic regulatory system (Florence).

• Develop and implement workflows and best practices that enhance regulatory oversight, documentation quality, and study compliance.

• Support audit and inspection readiness activities and assist with responses to regulatory findings, when necessary.

• Ensure adherence to Good Clinical Practice (GCP), institutional policies, sponsor requirements, and all applicable regulatory standards.

Required Qualifications:

• Demonstrated experience preparing and submitting IRB applications, including Initial Reviews, Amendments, Continuing Reviews, and Reportable Events.

• Strong knowledge of clinical research regulatory processes and documentation requirements.

• Excellent interpersonal skills with the ability to build and maintain effective working relationships across the Health System.

• Exceptional organizational skills with meticulous attention to detail.

• Ability to effectively manage multiple priorities, adapt to changing demands, and meet critical deadlines in a fast-paced environment.

• Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and implement corrective actions independently.

• Proven ability to exercise sound judgment, discretion, and independent decision-making.

• Excellent written and verbal communication skills.

• Ability to research, evaluate, interpret, and synthesize complex information and prepare clear, concise reports and correspondence.

• Strong customer service orientation and commitment to responsive stakeholder support.

• High level of professionalism, integrity, and discretion in handling confidential information.

• Ability to work independently while contributing effectively as part of a collaborative team.

• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams) and virtual meeting platforms such as Zoom.

• Demonstrated ability to establish and maintain accurate files, records, and regulatory documentation.

• Experience working effectively with individuals from diverse cultural, educational, and professional backgrounds.

Minimum Qualifications:

• High school diploma or equivalent combined with sufficient experience and demonstrated competencies required to successfully perform the duties of the position.

• Bachelor's degree preferred.

• Minimum of 3-5 years of clinical research regulatory experience as a Regulatory Affairs Coordinator (RAC) or Assistant Regulatory Affairs Coordinator, or an equivalent combination of education and experience.

Preferred Qualifications:

• Working knowledge of federal, state, local, and institutional regulations governing clinical research and human subject protections.

• Experience supporting a variety of clinical trial types, including industry-sponsored, federally funded, cooperative group, and investigator-initiated studies.

• Research certification such as ACRP, SoCRA, CCRP, or equivalent.

• Current CITI Human Subjects Research certification.

• Demonstrated expertise in clinical research regulatory compliance, including Phase I-IV drug studies and medical device trials.

• Comprehensive understanding of IRB processes, FDA regulations, and regulatory requirements throughout the clinical trial lifecycle.

• Experience with Clinical Trial Management Systems (OnCore) and electronic regulatory systems (Florence) preferred.

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