Clinical Research Regulatory Specialist
Clinical Research Regulatory Specialist
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$ 73735 - 96820
1 Vacancy
Job Description
The University of Southern California (USC) founded in 1880 is the largest private employer in the City of Los Angeles. As an employee of USC you will be a part of a world-class research university and a member of the Trojan Family which is comprised of the faculty students and staff that make the university what it is.
JOB SUMMARY:
Learns and masters the creation initiation development and revision of protocols informed consents case report forms and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support coordinating or performing a wide variety of administrative and
data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews including close-out and reporting. Updates all databases and regulatory binders with information pertinent to studying milestone progress. Maintains communication attends meetings and answers questions from all involved parties including regulatory bodies pharmaceutical companies principal investigators and colleagues.
JOB ACCOUNTABILITIES:
- Learns and masters the creation initiation development and revision of protocols informed consents case report forms and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board) ensuring trials are consistent with approved proposals to open new studies.
- Provides regulatory affairs support coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files including staff resumes licenses training certificates equipment receipts investigation logs etc. Reviews documentation as needed to support regulatory filings and maintains research files and documentation required by regulations.
- Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews including close-out and reporting. Interacting with research investigators and staff throughout the process from helping activate study and research trials to escalating problems and issues as needed. Provides support and clinical-specific training to staff maintaining and improving quality assurance training and development programs as needed.
- Updates all databases and regulatory binders with information pertinent to studying milestone progress including but not limited to: clinical trial management systems IRB databases internal and external spreadsheets and study electronic systems.
- Ensures compliance with all applicable local state and federal regulations statutes and laws and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines patient confidentiality (HIPAA) and any other applicable laws.
- Maintains communication attends meetings and answers questions from all involved parties including regulatory bodies (i.e. IRB) pharmaceutical companies (including monitors) principal investigators and colleagues. Works with clinical trial coordinators research staff and investigators to further communications helping remove obstacles impeding trial progress.
- Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs coordinates the reporting of serious adverse events and protocol deviations and proposes completes and submits amendments to protocols and trial forms and documentation as needed.
- Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.
Preferred Qualifications
Preferred Education: Bachelors degree
Preferred Experience: Three years
Supervises: No
Preferred Field of Expertise: Three years 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.
Special Instructions to Applicants:
Applicant Attachments (Required): Rsum & Cover Letter
The annual base salary range for this position is $73735.23 - $96820.08. 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 candidates 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 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 theBackground Screening Policy Appendix Dfor 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 or by email at. Inquiries will be treated as confidential to the extent permitted by law.
- Notice of Non-discrimination
- Employment Equity
- Read USCs Clery Act Annual Security Report
- USC is a smoke-free environment
- Digital Accessibility
If you are a current USC employee please apply to thisUSC job posting in Workday by copying and pasting this link into your browser:
Experience:Unclear Seniority
Employment Type
Full-Time
Key Skills
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