Regulatory Research Specialist

Location: Carmel, IN | Facility: Ascension St. Vincent Heart Center | Department/Specialty: Regulatory Research | Schedule: Full Time Days, Monday to Friday

About the role

Ascension is a leading nonprofit Catholic health system with a culture and associate experience grounded in service, growth, care and connection. We empower our 97,000+ associates to bring their skills and expertise every day to reimagining healthcare, together. Recognized as one of the Best 150+ Places to Work in Healthcare and a Military-Friendly Gold Employer, you’ll find an inclusive and supportive environment where your contributions truly matter.

Responsibilities

• Create and submit all required regulatory submissions related to research studies conducted by the organization.
• Coordinate, prepare, review, and submit required regulatory documentation.
• Review and recommend changes to departmental policies, procedures and standards commensurate with regulatory developments.
• Review and research pertinent trends, issues, and developments in research and disseminate information to staff.
• Maintain regulatory references and materials.
• Collaborate on the management of regulatory-related issues including serious adverse events and human subject participation.

Requirements

• High School diploma equivalency with 2 years of cumulative experience OR Associate's degree/Bachelor's degree OR 4 years of applicable cumulative job-specific experience.
• Research Professional licensure/certification/registration preferred.

Preferences

• 2 or 3 years of regulatory research experience in a hospital environment.

Benefits

• Comprehensive health coverage: medical, dental, vision, prescription coverage, and HSA/FSA options.
• Financial security & retirement: employer-matched 403(b), planning and hardship resources, disability and life insurance.
• Time to recharge: pro-rated paid time off (PTO) and holidays.
• Career growth: Ascension-paid tuition (Vocare), reimbursement, ongoing professional development, and online learning.
• Emotional well-being: Employee Assistance Program, counseling and peer support, spiritual care, and stress management resources.
• Family support: parental leave, adoption assistance, and family benefits.
• Other benefits: optional legal and pet insurance, transportation savings, and more.