Clinical Research Regulatory Supervisor

3 months ago

Newport Beach, United States DB Healthcare, Inc. Full time
Job DescriptionJob DescriptionTitle: Supervisor Regulatory - Clinical Research - CA
Type: Contract
Duration: 6 Months
Start Date: 07/08/2024
Schedule: 8:30am-4pm M-F

Job Summary:
The Clinical Research Regulatory Supervisor assists in overseeing clinical research regulatory operational activities.

Responsibilities:
  • Is responsible for conducting clinical research to industry standards and best practices.
  • Assists with ensuring proposed projects meet the mission and vision of Hoag and all Clinical Research stakeholders.
  • Assists the clinical research teams (physicians, nurses, etc.) by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout a clinical research study’s duration for studies involving human participants.
  • Ensures all research studies are compliant with regulations and maintains accurate, up-to-date, regulatory files.
  • Is the central resource for staff.
  • Manage the day-to-day clinical research regulatory operations ensuring regulatory responsibilities are completed correctly and completely.
  • Interact daily with team to ensure Study compliance.
  • Oversees the process of informed consents to include institutional language.
  • Works with legal/sponsors to ensure CTA language is consistent with consent.
  • Designs, implements, and manages a system for organizing, planning work-flow related to all research regulatory study activities including developing organizational forms and tools to conduct the study accurately and in compliance with Good Clinical Practice, to facilitate study completion and compliance.
  • Is up to date on current federal, state, and local regulations and communicates changes to study team.
  • Works closely with Director Clinical Research – Finance & Regulatory.
  • Provides institutional authorization for new submissions with IRB.
  • Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
  • Registers & maintains clinical trials on clinical trials gov website for applicable studies and works with sponsors to include Hoag.
  • Maintains and updates the study management portion of the department’s clinical trial management system.
  • Maintains Institution’s Federal Wide Assurance to ensure Hoag remains current and compliant.
  • Assists in the development, writing, and maintenance of SOPs including work instructions, forms, and templates.
  • Other duties as assigned.
Required Skills:
  • 5+ years' experience with Clinical Research.
  • Understands and keeps current with FDA and Medicare regulations and/or third-party insurance guidelines applicable to clinical trials.
  • Is knowledgeable of Clinical Research study protocols and internal SOPs.
  • Excellent communication and organizational skills required.
Education:
  • High School Graduate or equivalent required.
  • Bachelors' Degree preferred.

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