Regulatory Lead – Clinical Trials (8-Month)

USC University of Southern California; San Diego (CA); On-site; USD 73,000 - 89,000; Full time

Job summary

The University of Southern California, Keck School of Medicine, Alzheimer Therapeutic Research Institute (ATRI) in San Diego, California, is seeking a Clinical Research Regulatory Specialist on a fixed-term eight-month appointment to ensure regulatory compliance for ATRI’s multi-center trials.

Under the ATRI Clinical Research Regulatory Manager and Director of Administration, you will review consent forms, prepare IIPs, initiate IRB submissions, track startup activities, and manage essential

Qualifications

• 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 FDA for Investigational Drugs and Devices (IND/IDE).
• Knowledgeable of ICH-GCP, DHHS, OHRP and FDA regulations and procedures.
• Ability to evaluate risks and benefits of different solutions and to communicate effectively with diverse stakeholders.
• Demonstrated ability to develop communication plans and instructional materials.

Responsibilities

• Review site-specific informed consent forms for consistency with the protocol and regulatory requirements.
• Prepare Investigator Initiation Packages for distribution to clinical trial sites.
• Initiate IRB submissions through USC iStar and Advarra IRB for ATRI trials.
• Track start-up activities and provide updates to Project Directors, Sponsors and ATRI Leadership.
• Distribute, collect, process and track Essential Site Regulatory Documents for ATRI trials and collect updated CVs, licenses and training certificates.
• Review and upload documents into study-specific eTMF systems.

Skills

Attention to detail

Strong writing skills

Organizational skills

Prioritize tasks

Problem solving

Education

Bachelor's degree

Tools

iStar system

Advarra IRB

Google Drive

Microsoft Word

Microsoft Excel

Outlook

eTMF systems

Job description

The University of Southern California, Keck School of Medicine, Alzheimer Therapeutic Research Institute (ATRI) in San Diego, California, is seeking a Clinical Research Regulatory Specialist on a fixed-term eight-month appointment to ensure regulatory compliance for ATRI’s multi-center trials.

Under the ATRI Clinical Research Regulatory Manager and Director of Administration, you will review consent forms, prepare IIPs, initiate IRB submissions, track startup activities, and manage essential