University of Southern California

Clinical Research Regulatory Specialist

LOS ANGELES, CAPosted 25 days ago

Job summary

  • Job post source

    This job is directly from University of Southern California

  • Job overview

    The Clinical Research Regulatory Specialist at USC supports principal investigators by managing clinical research documentation and ensuring regulatory compliance to facilitate high-quality clinical investigations.

  • Responsibilities and impact

    The role involves creating and revising research protocols, submitting documents to regulatory bodies, maintaining electronic regulatory files, supporting compliance reviews, updating databases, ensuring adherence to regulations like FDA and HIPAA, and coordinating communication among stakeholders.

  • Compensation and benefits

    The annual base salary range is $73,735.23 to $96,820.08, with consideration of experience, education, and other factors; benefits details are not specified.

  • Experience and skills

    Requires a bachelor's degree and at least two years of experience in clinical research compliance or regulatory operations, knowledge of FDA and IRB submissions, and strong organizational and communication skills; three years experience preferred.

  • Company information

    USC is a world-class research university founded in 1880 and the largest private employer in Los Angeles, known for its strong academic community called the 'Trojan Family'.

  • Application process

    Applicants must submit a résumé and cover letter as part of the application process.

  • Unique job features

    The position involves working with advanced regulatory frameworks and supporting clinical research compliance in an academic setting, emphasizing quality assurance and human subject protection.

Company overview

The University of Southern California (USC) is a premier private research university located in Los Angeles, California. Established in 1880, USC offers a wide range of undergraduate, graduate, and professional programs across various disciplines, including business, engineering, law, and the arts. The university generates revenue through tuition fees, research grants, and donations, and it is known for its strong emphasis on innovation, interdisciplinary research, and global engagement. USC's notable alumni network and partnerships with industry leaders provide significant opportunities for career advancement and professional development.

How to land this job

  • Tailor your resume to emphasize your expertise in clinical research compliance, regulatory affairs, and experience with protocol development and submissions to Institutional Review Boards and FDA, highlighting familiarity with ICH-GCP and FDA regulations.

  • Showcase your organizational skills and attention to detail, particularly your ability to maintain regulatory binders, update databases, and manage clinical trial documentation accurately and efficiently.

  • Apply through multiple channels including the University of Southern California's official careers page and LinkedIn to maximize your chances of being noticed for this Clinical Research Regulatory Specialist role.

  • Connect with current employees in USC's Clinical Investigations Support Office or related research regulatory divisions on LinkedIn; start conversations by referencing recent USC clinical research initiatives or asking about challenges in maintaining compliance with evolving FDA regulations.

  • Optimize your resume for ATS by incorporating keywords such as 'clinical research compliance,' 'regulatory submissions,' 'ICH-GCP,' 'FDA regulations,' 'protocol development,' and 'IRB submissions' to ensure your application passes automated screenings effectively.

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