Clinical Research Regulatory Lead for NIH Trial

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

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.