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Job Type:
Regular
Scheduled Hours:
40
Why You’ll Love Working with St. Elizabeth Healthcare
At St. Elizabeth Healthcare, every role supports our mission to provide comprehensive and compassionate care to the communities we serve. For more than 160 years, St. Elizabeth Healthcare has been a trusted provider of quality care across Kentucky, Indiana, and Ohio. We’re guided by our mission to improve the health of the communities we serve and by our values of excellence, integrity, compassion, and teamwork. Our associates are the heart of everything we do.
Benefits That Support You
We invest in you — personally and professionally.
Enjoy:
- Competitive pay and comprehensive health coverage within the first 30 days.
- Generous paid time off and flexible work schedules
- Retirement savings with employer match
- Tuition reimbursement and professional development opportunities
- Wellness, mental health, and recognition programs
- Career advancement through mentorship and internal mobility
Job Summary:
The Specialist – Regulatory Affairs will apply a comprehensive understanding of research regulations, ethics and guidelines, and analyze research IRB submissions to determine compliance with regulation. Oversee the review and correspondence of research regulatory data. Use independent judgment to interpret, analyze, and apply federal, state, and SEH policies to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators. Act as a liaison between IRB and research team to promote information flow. Ensure study documentation remains in compliance with study protocols.
Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background.
Job Description:
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Prepare, review, and execute regulatory submissions to the IRB and other regulatory authorities for the CRI.
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Serve as a regulatory contact and provide regulatory-related study updates to CRI staff, physicians and physicians.
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Oversee CRI study start-up from the regulatory standpoint to ensure that site meet Sponsors, IRB, and other regulatory authority’s requirements.
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Manage the maintenance of the site certifications (CLIA, DEA, etc. and all Sub-I / PI staff credentials (CV, medical license, DEA form, etc).
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Be the liaison with the sponsoring agency for regulatory approvals throughout the life of the study.
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Disseminate regulatory information and participate in training.
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Provide guidance and serve as a resource to co-workers.
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Supply direction and feedback to research team to ensure awareness of business practices and quality standards.
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Participate in internal and external audits, and regulatory authority inspections.
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Customer Service – Align with the mission, vision, and values of SEH.
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Communication – Demonstrate clear, diplomatic, effective oral and written communication and exhibit initiative, effort, resourcefulness, and professional demeanor in a timely manner.
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Attend research team meetings to provide updates and report regulatory issues.
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Develop and maintain the regulatory and essential documents to be in compliance with Standard Operating Procedures (SOP) and Practice Guidelines (PG).
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Performs other duties as assigned.
Education, Credentials, Licenses:
- Bachelor’s Degree in related area of study.
Specialized Knowledge:
Understanding of research processes
Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines. Proficiency with Excel, Word, Outlook and PowerPoint is imperative. Ability to work effectively and in a professional manner with physicians, leadership, SEH/SEP associates, patients, external business partners, representatives of regulatory agencies and the general public.
Kind and Length of Experience:
3 year’s related experience in specialty area.
FLSA Status:
Exempt
Right Career. Right Here. If you're looking for the right careers in healthcare, the right place to be is at St. Elizabeth. Join us, and you'll take pride in the level of care we offer our community.
