- The Clinical Research Regulatory Supervisor assists in overseeing clinical research regulatory operational activities_.
- 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 startup 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, uptodate, regulatory files.
- Is the central resource for staff. Manage the daytoday clinical research regulatory operations ensuring regulatory responsibilities are completed correctly and completely.
- Interact daily with the team to ensure Study compliance.
- Oversees the process of informed consent to include institutional language.
- Works with legal/sponsors to ensure CTA language is consistent with consent.
- Designs, implements, and manages a system for organizing and planning workflow 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 the study team.
- Works closely with the Director of 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 and develops and implements systems to decrease delay in the approval process.
- Registers & maintains clinical trials on the 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 the 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.
- High School Graduate or equivalent required
- Bachelors' Degree or Five plus (5+) years' experience with Clinical Research.
- Excellent communication and organizational skills are required.
- Understands and keeps current with FDA and Medicare regulations and/or thirdparty insurance guidelines applicable to clinical trials required.
- Is knowledgeable of Clinical Research study protocols and internal SOPs required.
- Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives._
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Supervisor Regulatory Clinical Research - Newport Beach, United States - Hoag Memorial Hospital Presbyterian
Description
Salary Range:
$ $ /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.
Education and Experience
Required:
