Clinical Research Regulatory Specialist

University of Southern California • Los Angeles, CA

396d • $71,483 - $96,820

About The Position

The Clinical Research Regulatory Specialist at the University of Southern California (USC) is responsible for supporting principal investigators and quality assurance systems by managing the creation, initiation, and revision of clinical research documentation. This role involves providing regulatory affairs support, coordinating administrative and data management activities, and ensuring compliance with applicable regulations. The specialist will also facilitate communication among various stakeholders and assist in training staff to maintain high-quality research standards.

Requirements

• Bachelor's degree in a relevant field.
• Minimum of 2 years of experience in clinical research compliance, regulatory research, 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).
• Knowledge of ICH-GCP, DHHS, OHRP, and FDA regulations and procedures.
• Ability to evaluate risks and benefits of solutions with proven problem-solving skills.
• Exemplary organization skills and attention to detail.
• Ability to interpret, analyze, and apply relevant policies and regulations.
• Strong interpersonal and diplomatic skills for effective communication with diverse individuals and groups.
• Experience developing communication plans and instructional materials.
• Familiarity with office management communication software/tools (e.g., Google suite, Slack, Skype).

Nice To Haves

• Three years of experience in clinical research compliance, regulatory research, and/or operations.
• Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials.
• Advanced knowledge of regulations governing human research.

Responsibilities

• Learn and master the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study documentation.
• Submit protocols and supporting documents to internal and external regulatory bodies, ensuring trials are consistent with approved proposals.
• Provide regulatory affairs support, coordinating a variety of administrative and data management activities for research project goals.
• Manage and maintain electronic regulatory files, including staff resumes, licenses, training certificates, and investigation logs.
• Review documentation to support regulatory filings and maintain research files required by regulations.
• Support and facilitate clinical research by preparing and conducting compliance reviews, including close-out and reporting.
• Interact with research investigators and staff to activate study trials and escalate issues as needed.
• Provide clinical-specific training to staff and improve quality assurance training programs.
• Update databases and regulatory binders with information pertinent to study milestone progress.
• Ensure compliance with local, state, and federal regulations, including IRB and FDA guidelines.
• Maintain communication with regulatory bodies, pharmaceutical companies, principal investigators, and colleagues.
• Participate in centralized activities to support research regulatory requirements and coordinate educational efforts.
• Identify compliance training needs and report serious adverse events and protocol deviations.

Benefits

• Annual base salary range of $71,483.04 - $96,820.08
• Diversity and equal opportunity in employment
• Support for professional development and training

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Educational Services
• Education Level: Bachelor's degree