Research Regulatory Specialist

Responsibilities

• Under limited supervision performs essential duties related to the regulatory management of clinical trial research along with the maintenance and troubleshooting of the clinical trials management system (CTMS) which houses Baptist Health’s research operations data
• Obtains and maintains an awareness of industry regulatory trends, organizational developments, and hospital/clinical research center strategies that could influence the success of regulatory projects
• Provides clinical trial regulatory training and guidance to staff throughout the system
• Assists in the extraction, analysis, and reporting of regulatory and operations data
• Establishes and maintains knowledge of database design, data definitions, system capabilities, and data integrity issues
• THIS POSITION LEADS THE PROTOCOL AMENDMENT PROCESSING FOR ALL INDUSTRY SPONSORED RESEARCH

Preferred

• 1 year of Regulatory experience
• familiarity with Florence and Verily

Benefits

• Fully remote work position
• Glassdoor
• 3.9
• Full-spectrum healthcare system serving Kentucky and Southern Indiana.
• Sunrise, Florida, USA
• https://www.baptisthealth.com/
• Late Stage
• Leadership Team
• Gerard Colman
• Chief Executive Officer
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Qualifications

• Bachelor's Degree in basic science or health related field
• Minimum 2 years clinical research experience
• Minimum 2 years' experience with research related databases
• 1 year of Regulatory experience
• Familiarity with Florence and Verily
• Minimum 2 years clinical research experience.

Required skills

• , Research Regulatory Management, Florence, Verily

Preferred skills

• 1 year of Regulatory experience, familiarity with Florence and Verily

Experience

• 2+ years