Research Regulatory Specialist

Responsibilities

• Ensure compliance with institutional, sponsor, and governmental policies and laws for assigned research team members and clinical research projects.
• Act as a liaison between sponsors, Clinical Research Operations, Institutional Review Board, and internal departments/staff to complete initial Institutional Review Board protocol submissions.
• Submit study amendments in a timely manner, including changes to the protocol, consent forms, and other study documents.
• Prepare for and facilitate monitoring visits, ensuring study regulatory files are up-to-date and audit-ready.
• Aid in the development of protocol-specific standard operating procedures and train Clinical Research Coordinators on guidelines related to consent, ethical conduct, and protection of human subjects.

Requirements

• Master's Degree in a related field with 1 year of research, regulatory, or healthcare administration experience.
• Bachelor's Degree in Business, Healthcare Management, Nursing, or a related field with 2 years of research regulatory or healthcare administration experience.
• High School Diploma with 5 years of research regulatory experience.

Qualifications

• Extensive knowledge of FDA regulations and human subjects protection.
• PREFERRED: SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research Professionals), CCRC (Certified Clinical Research Coordinator).

Benefits

• Competitive total reward package including benefits (medical, dental, vision)
• Paid time off
• Tuition assistance
• 401K match and additional yearly contribution
• Annual performance appraisals and team award bonus
• Family resources and wellness opportunities
• Community perks and discounts