Senior Specialist, Regulatory Operations
J
JobgetherClinical Research
Fully remote work environment within the United States or Canada.Full-TimeSenior
Salary90,000 - 100,000 USD per year
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Job Details
- Experience
- Minimum of 4 years
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in a scientific, healthcare-related, or equivalent field (advanced degree preferred).
- Minimum of 4 years of experience in regulatory operations within clinical research sites, CROs, or pharmaceutical companies.
- Strong understanding of U.S. regulatory requirements, FDA regulations, and ICH Good Clinical Practice (GCP) guidelines.
- Proven experience managing IRB submissions, regulatory documentation, and ongoing compliance.
- Experience supporting clinical trial site operations throughout the full study lifecycle.
- Familiarity with electronic Investigator Site File (eISF) systems like Florence or CRIO.
- Strong organizational skills with the ability to prioritize multiple tasks in a fast-paced environment.
- Excellent written and verbal communication skills.
- Strong problem-solving abilities and a proactive approach to regulatory challenges.
- Proficiency with Microsoft Office (Word, Excel) and clinical trial databases.
Responsibilities
- Lead regulatory operational activities for assigned clinical trials, ensuring compliance with FDA guidelines, OHRP standards, and ICH GCP principles.
- Support site-level regulatory activities, including study start-up, ongoing maintenance, and close-out processes.
- Develop and implement regulatory strategies that enable efficient site operations.
- Coordinate preparation, review, submission, and tracking of IRB materials, including protocols, informed consent forms, and amendments.
- Manage essential regulatory records, ensuring Investigator Site Files are inspection-ready and compliant.
- Support site teams through key milestones including site evaluation, initiation, and study closeout.
- Prepare for and support sponsor monitoring visits, audits, and regulatory inspections.
- Monitor regulatory updates and provide guidance on changing requirements.
- Partner with Clinical Operations and Quality teams to strengthen regulatory workflows.
- Contribute to the creation and maintenance of SOPs, work instructions, and departmental processes.
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