Clinical Research Regulatory Specialist

 

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s disease (AD) through innovative clinical trials. 

 

The Clinical Research Regulatory Specialist will be responsible for ensuring regulatory compliance for multi-center clinical trials managed by the ATRI at the time of study start up, for the duration of the trial and study closure of the trial. This position will work under the direction of the ATRI Clinical Research Regulatory Manager and Director of Administration.

 

 Job Functions include: 

·         Review site-specific informed consent forms for consistency with the protocol, approved study templates, regulatory requirements, and study procedures.

·         Preparation of Investigator Initiation Packages (IIPs) for distribution to clinical trial sites. 

·         Initiate IRB submission through USC iStar system and Advarra IRB (central IRB) for ATRI clinical trials. 

·         Tracking study start-up activities for multi-center clinical trials and providing regular updates to Project Directors, Sponsors and ATRI Leadership 

·         Distribution, collection, processing and tracking of Essential Site Regulatory Documents for ongoing ATRI clinical trials, including collection of updated Investigator CVs, licenses, GCP and human subjects training certificates. 

·         Review and upload of essential documents into study-specific electronic Trial Master File (eTMF) systems

 

Specific Job Qualifications 

·         High attention to detail and strong writing skills are essential.  

·         Organizational and follow-through skills are required. Individual must be able to successfully prioritize tasks and complete assignments under strict time deadlines. 

·         Ability to think creatively and problem solve. Work environment encourages individuals to think creatively and to develop systems to continuingly improve day to day functions and tasks using technologies available.  

 

Preferred Requirements:

·         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

 

 

The annual base salary range for this position is $73,092.61 - $89,042.90. 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.

 

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. 

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 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

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.

                                                  

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