Clinical Research Regulatory Specialist
About The Position
The Clinical Research Regulatory Specialist ensures regulatory compliance for multi-center clinical trials managed by the Alzheimer Therapeutic Research Institute (ATRI) at study start-up, throughout the trial, and at study closure. The position works under the direction of the ATRI Clinical Research Regulatory Manager and Director of Administration. The role supports clinical trial regulatory activities, including reviewing site-specific informed consent forms, preparing investigator initiation packages, initiating IRB submissions, tracking study start-up activities, and managing essential site regulatory documents. It also involves reviewing and uploading essential documents into study-specific electronic Trial Master File (eTMF) systems. This is a fixed-term appointment for 8 months. The annual base salary range is $73,092.61–$89,042.90. USC considers factors including position scope and responsibilities, experience, education and training, skills, internal equity, legal requirements, funding, and market and organizational considerations when extending an offer.
Requirements
- Bachelor's degree; combined experience and education may substitute for the minimum education requirement.
- At least 2 years of experience; combined experience and education may substitute for the minimum work experience requirement.
- 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).
- Knowledge of ICH-GCP, DHHS, OHRP, and FDA regulations and procedures.
- Ability to evaluate risks and benefits of different solutions, with problem-solving and decision-making skills to identify causes of problems.
- Strong organizational skills and attention to detail.
- Ability to interpret, analyze, and apply relevant policies, procedures, regulations, and requirements.
- Interpersonal and diplomatic skills for communicating tactfully with staff at all levels and with varied individuals and groups.
- Demonstrated experience developing communication plans, instructional materials, and related content.
- Experience with office management communication software and tools such as Google Suite, Slack, and Skype.
- High attention to detail and strong writing skills.
- Organizational and follow-through skills, including ability to prioritize tasks and complete assignments under strict deadlines.
- Ability to think creatively and solve problems, and to develop systems that continually improve day-to-day functions and tasks using available technologies.
Nice To Haves
- Experience with FDA, GCP, and OHRP.
- Previous regulatory experience.
- Previous experience with eTMF systems.
- Proficiency in Microsoft Office (Word, Excel, Outlook) and Google Drive platforms.
- Bachelor's degree (preferred education).
- 3 years of experience in clinical research compliance, regulatory research, and/or operations in the academic or private sector.
- Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials.
- Advanced knowledge of regulations governing human research.
Responsibilities
- Review site-specific informed consent forms for consistency with the protocol, approved study templates, regulatory requirements, and study procedures.
- Prepare Investigator Initiation Packages (IIPs) for distribution to clinical trial sites.
- Initiate IRB submissions through the USC iStar system and Advarra IRB (central IRB) for ATRI clinical trials.
- Track study start-up activities for multi-center clinical trials and provide regular updates to Project Directors, Sponsors, and ATRI Leadership.
- Distribute, collect, process, and track essential site regulatory documents for ongoing ATRI clinical trials, including updated Investigator CVs, licenses, GCP certificates, and human subjects training certificates.
- Review and upload essential documents into study-specific electronic Trial Master File (eTMF) systems.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
