Research Regulatory Specialist

BHS • Kentucky - Work from Home, KY

3d • Remote

About The Position

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.

Requirements

• Bachelor’s Degree in basic science or health related field
• Minimum 2 years clinical research experience
• Minimum 2 years' experience with research related databases

Nice To Haves

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

Responsibilities

• Regulatory management of clinical trial research
• Maintenance and troubleshooting of the clinical trials management system (CTMS)
• Obtaining and maintaining an awareness of industry regulatory trends, organizational developments, and hospital/clinical research center strategies
• Providing clinical trial regulatory training and guidance to staff
• Assisting in the extraction, analysis, and reporting of regulatory and operations data
• Establishing and maintaining knowledge of database design, data definitions, system capabilities, and data integrity issues
• Leading the protocol amendment processing for all industry-sponsored research

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level