Baptist Health Jobs

Research Regulatory Specialist

Baptist Health

Research Regulatory Specialist

Posted 6 Days Ago

Be an Early Applicant

Remote

Hiring Remotely in Kentucky, USA

Junior

Remote

Hiring Remotely in Kentucky, USA

Junior

Manages clinical trial regulatory activities, including protocol amendment processing for industry-sponsored research. Maintains and troubleshoots the clinical trials management system, supports regulatory training and guidance, monitors industry and organizational developments, and assists with regulatory and operational data extraction, analysis, and reporting. Ensures knowledge of database design, data definitions, system capabilities, and data integrity.

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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 or 2 years’ additional experience may be substituted for a degree.
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!

Baptist Health is an Equal Employment Opportunity employer.

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