Research Regulatory Specialist

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

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, Baptist Health is an Equal Employment Opportunity employer. Founded in 1924 in Louisville, Kentucky, Baptist Health is a full-spectrum health system dedicated to improving the health of the communities it serves. The Baptist Health family consists of 10 hospitals, employed and independent physicians, and more than 470 points of care, including outpatient facilities, physician practices and services, urgent care clinics, outpatient diagnostic and surgery centers, home care, fitness centers, and occupational medicine and physical therapy clinics. Baptist Health’s eight owned hospitals include more than 2,300 licensed beds in Corbin, Elizabethtown, La Grange, Lexington, Louisville, Paducah, Richmond and New Albany, Indiana. Baptist Health also operates two joint venture hospitals: the 410-bed Baptist Health Deaconess Madisonville in Madisonville, Kentucky with Deaconess Health System based in Evansville, Indiana, and the Baptist Health Rehabilitation Hospital, a 40-bed inpatient rehabilitation facility with Encompass Health, based in Birmingham, Alabama. Baptist Health employs more than 24,000 people in Kentucky and surrounding states. Baptist Health is the first health system in the U.S. to have all of its hospitals recognized by the American Nursing Credentialing Center with either a Magnet® or Pathway to Excellence® designation for nursing excellence. Baptist Health’s employed provider network, Baptist Health Medical Group, has more than 1,820 employed providers offering care in 78 specialties, including approximately 862 physicians and 958 advanced practice clinicians. Baptist Health’s physician network also includes more than 2,000 independent physicians.

EEO Statement: Baptist Health is an Equal Employment Opportunity employer, and seeks to employ individuals without regard to race, color, national origin, gender, sexual orientation, gender identity, age, disability, marital status, citizenship status, military status, religious or political beliefs, protected veteran status, employment status or any other protected class identified in any federal, state, or local law. Baptist Health specifically encourages minority, female, disabled, veteran and other candidates from diverse backgrounds to apply and strengthen our team.

Please note that Baptist Health is a drug-free workplace and employment with Baptist Health is subject to post offer, pre-employment drug testing.

NOTICE OF NONDISCRMISSION AND ACCESSIBILITY TO SERVICES Persons with hearing and speech impairments can contact Baptist Health facilities by using the Kentucky Relay Service, a toll-free telecommunication device for the deaf (TDD). For voice to TDD, call 800.648.6057. For TDD to voice, call 800.648.6056.