Clinical Research Regulatory Specialist

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

Fixed Term Appointment for 8 months 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

Fixed Term Appointment for 8 months

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.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. 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. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at [phone], or by email at [e-mail]. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC’s Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility

USC is a leading private research university located in the heart of downtown Los Angeles – a global center for arts, technology and international business. As the largest private employer in the city – responsible for more than $5 billion annually in economic activity in the region – we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills. As a USC employee, you will enjoy excellent benefits and perks, and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work.