Clinical Research Regulatory Specialist

USC Department of Surgery is recruiting a Clinical Research Regulatory Specialist for our Clinical Research Division. The Research Regulatory Specialist will learn and master the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems. The Clinical Research Regulatory Specialist will also provide regulatory affairs support, coordinate and perform a wide variety of administrative and data management activities for research-project goals.

In addition, the Clinical Research Regulatory Specialist will help prepare and conduct high-quality compliance reviews, including close-out and reporting, update all databases, and regulatory binders with information pertinent to studying milestone progress and maintain communication with PI's, attend meetings, and answer questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.

The annual base salary range for this position is $71,483.04 - $85,000. 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 organization considerations.

Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education
Minimum Experience: 2 years, 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 diverse 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.