Research Regulatory Specialist

Baptist Health; Louisville (KY); Remote; USD 65,000 - 90,000; Full time

Job summary

Baptist Health is seeking a Research Regulatory Specialist to join our team. This fully remote role includes occasional travel to Louisville and Lexington for meetings.

The incumbent will manage regulatory aspects of clinical trials, maintain the CTMS, provide staff training, analyze data, and lead protocol amendment processing for industry-sponsored research.

Strong knowledge of regulatory trends and data integrity is required.

Qualifications

• Bachelor's degree required in a basic science or health-related field
• Minimum 2 years clinical research experience
• Minimum 2 years' experience with research related databases

Responsibilities

• Lead the protocol amendment processing for all industry-sponsored research.
• Manage regulatory aspects of clinical trials and maintain the CTMS.
• Provide regulatory training and guidance to staff across the system.
• Assist in extraction, analysis, and reporting of regulatory and operations data.
• Maintain knowledge of data definitions, system capabilities and data integrity issues.

Skills

Clinical research experience

Database experience

Regulatory training

Education

Bachelor's degree in basic science or health related field

Tools

Florence

Verily

Job description

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.

Baptist Health is an Equal Employment Opportunity employer.