Clinical Research Regulatory Specialist

USC’s Keck School of Medicine, Department of Medicine, is seeking a  Clinical Research Regulatory Specialist.

USC's Keck School of Medicine, Department of Medicine, is seeking a Clinical Research Regulatory Specialist to join its team. The Clinical Research Regulatory Specialist is part of the Medicine Research Unit (MRU) and is responsible for providing regulatory affairs support to the Medicine Research Unit.

The Clinical Research Regulatory Specialist works closely with the Clinical Research Program staff and supports principal investigators.  The candidate’s duties include:

• High-quality compliance review and coordinates all work to shepherd protocols and open studies in a timely manner
• Removes obstacles from study activation, influencing timely IRB submission
• Liaises with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws, resolving issues and problems, negotiating compromises, and proposing alternatives and recommendations to facilitate and expedite research
• Ensures regulatory compliance for multiple clinical trials, initiating, revising and overseeing all regulatory aspects of the study start-up process
• Oversees data management activities and maintenance of electronic regulatory files and binders with information pertinent to studying milestone progress
• Maintains awareness of new and updated rules and regulations, alerting appropriate staff to changes, and ensure appropriate interpretation and application to new and existing studies and trial

Overall, the successful candidate will have experience working in a clinical trials research environment, have research certification, have excellent organizational skills, work well as a member of a small research team, be able to work independently, and have the ability to interact well with study staff members.  Candidate will work with the PI, department, sponsor, and institution to provide assistance involving regulatory affairs and IRB processes.  

Rate Information:

This position will be Exempt and Hybrid-Flex.

The salary range for this position is $71,483.04 – $80,000.00.

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.

Other Information:

Preferred Education: Masters Degree

Preferred Experience: 5 years of clinical research

Preferred Field of Expertise: Clinical research

Percentage of Time: 100%

Fixed Term?   No

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 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.