7 Supervisor Regulatory - Clinical Research Jobs in Newport, CA
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Supervisor Regulatory - Clinical Research
$151k-195k (estimate)
Full Time
5 Days Ago
Huckeye Health Services LLC is Hiring a Supervisor Regulatory - Clinical Research Near Newport, CA
Duties:
- Oversee clinical research regulatory operations.
- Ensure compliance with industry standards and regulations.
- Facilitate study start-up approval and maintain regulatory documentation.
- Serve as the central resource for regulatory compliance.
- Manage day-to-day regulatory operations and ensure study compliance.
- Oversee informed consent process and ensure consistency with CTA language.
- Develop systems for organizing regulatory activities.
- Communicate regulatory updates to the study team.
- Work with the Director of Clinical Research – Finance & Regulatory.
- Provide institutional authorization for new IRB submissions.
- Track and streamline IRB/subcommittee approval processes.
- Register and maintain clinical trials on ClinicalTrials.gov.
- Maintain study management in the clinical trial management system.
- Ensure the institution's Federal Wide Assurance is current.
- Develop and maintain SOPs, work instructions, forms, and templates.
- Excellent communication and organizational skills.
- Knowledge of FDA and Medicare regulations and clinical trial guidelines.
- Familiarity with Clinical Research study protocols and SOPs.
- Minimum of 5 years of regulatory experience.
- 3-5 years of management experience.
- Preferably experienced in smaller/private clinic settings.
- Comfortable managing a high volume of trials (175) and a staff of 5.
- Cancer, WCG Ibarra experience preferred.
- High School Graduate or equivalent.
- Bachelor's Degree or 5 years' experience in Clinical Research.
Job Summary
JOB TYPE
Full Time
SALARY
$151k-195k (estimate)
POST DATE
06/22/2024
EXPIRATION DATE
08/21/2024
WEBSITE
huckeyehealthcare.com
HEADQUARTERS
Katy, TX
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