Clinical Research Regulatory Specialist

University of Southern California; Glendale (CA); On-site; USD 65,000 - 88,000; Full time

Job summary

University of Southern California is seeking a clinical research regulatory specialist to support a NIH RF1-funded stroke trial. The role involves managing daily operations, coordinating visits, and ensuring regulatory compliance over a one-year span.

The candidate will ensure accurate records, IRB/IND submissions, and adherence to ICH-GCP and FDA regulations, while coordinating lab resources and staff training. This full-time position is based in the USC community.

Qualifications

• Bachelor’s degree required; combined education/experience acceptable.
• Minimum 2 years in clinical research.
• Experience with IRB/IND/IDE submissions.
• Knowledge of ICH-GCP and FDA regulations.
• Strong organizational and communication skills.
• Experience with office software (Google Suite, Slack, Skype).

Responsibilities

• Manage day-to-day clinical research operations: recruitment, scheduling, data collection, study visit coordination, data entry and verification, staff training, and communications.
• Oversee laboratory resource utilization: procurement, inventory control, and general laboratory safety.
• Maintain complete and accurate clinical research records, study files, training records and lab documentation, ensuring compliance with guidelines.

Skills

Clinical research compliance

IND/IDE submissions

IRB submissions

FDA regulations

Organizational skills

Communication skills

Problem solving

Education

Bachelor's degree

Tools

Google Suite

Slack

Skype

Job description

This is a full time staff position with an annual compensation of $75,968.95/year.

We are seeking a clinical research regulatory specialist to assist with the development and management of an NIH RF1-grant funded clinical trial in which individuals with stroke will be enrolled and participate in study activities over the course of one year.

• The candidate will manage and support day-to-day clinical research operations, including participant recruitment, scheduling, data collection, study visit coordination, data entry and verification, staff training, and communications.
• The candidate will also oversee laboratory resource utilization by overseeing supply procurement, inventory control, and general clinical laboratory safety.
• The candidate will also maintain complete and accurate clinical research records, study files, training records and laboratory documentation, ensuring all activities comply with federal and institutional guidelines.

Minimum Education: Bachelor's degree

Additional Education Requirements Combined experience/education as substitute for minimum education

Minimum Experience: 2 years

Additional 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 or Masters degree in a life science field or related, with specific experience in clinical research and lab management.

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.

Job ID REQ20177782

Posted Date 07/25/2026