Remote Research Regulatory Specialist for Clinical Trials

BHS Baptist Healthcare System; Kentucky; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Baptist Health is seeking a Research Regulatory Specialist to join our team in a fully remote role with occasional travel to Louisville and Lexington for meetings. Under limited supervision, you will manage regulatory aspects of clinical trial research, maintain the CTMS, train staff, and extract/analyze data.

This position leads the protocol amendment processing for all industry-sponsored research and stays current with regulatory trends.

Qualifications

• Bachelor’s Degree in basic science or health-related field, or 2 years’ additional experience.
• 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

• Leads the protocol amendment processing for all industry-sponsored research.
• Manages regulatory aspects of clinical trial research and CTMS maintenance.
• Provides regulatory training and guidance to staff across the system.
• Assists in extraction, analysis, and reporting of regulatory and operations data.
• Maintains knowledge of database design, data definitions, and data integrity issues.

Skills

Clinical research

Regulatory knowledge

Education

Bachelor's degree in basic science or health-related field

2 years of related experience (substitution for degree)

Tools

Florence

Verily

Job description

Baptist Health is seeking a Research Regulatory Specialist to join our team in a fully remote role with occasional travel to Louisville and Lexington for meetings. Under limited supervision, you will manage regulatory aspects of clinical trial research, maintain the CTMS, train staff, and extract/analyze data.

This position leads the protocol amendment processing for all industry-sponsored research and stays current with regulatory trends.