Research Regulatory Specialist

Baptist Health; Kentucky; Remote; USD 65,000 - 90,000; Full time

Job summary

Baptist Health is seeking a Research Regulatory Specialist for a fully remote role with occasional travel to Louisville and Lexington for meetings. The role focuses on regulatory management of clinical trial research and CTMS upkeep, ensuring data integrity across Baptist Health’s research operations.

Ideal candidates hold a life sciences degree and at least two years in clinical research with databases; familiarity with Florence/Verily preferred.

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.
• Preferred: 1 year of Regulatory experience; familiarity with Florence and Verily.

Responsibilities

• Regulatory management of clinical trial research across Baptist Health.
• Maintenance and troubleshooting of the CTMS housing research operations data.
• Lead the protocol amendment processing for all industry sponsored research.
• Provide regulatory training and guidance to staff system-wide.
• Assist in extraction, analysis and reporting of regulatory and operations data.
• Establish and maintain knowledge of database design, data definitions, and data integrity issues.

Skills

Clinical research

Database management

Regulatory training

Analytics

Education

Bachelor's degree in life sciences

Tools

Florence

Verily

CTMS

Job description

## Research Regulatory SpecialistApply: Kentucky: Full time: Posted Today: R26108284**Summary****Job Description:*****Baptist Health is looking for a Research Regulatory Specialist to join our team! This Is a fully remote work position with occasional travel to Louisville and Lexington for meetings.*** 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.***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 ***Preferred:***1 year of Regulatory experience; familiarity with Florence and Verily.### *If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now!*