IRB & Clinical Research Operations Expert

Healthcare Staffing; United States; On-site; USD 70,000 - 90,000; Full time

Job summary

Healthcare Staffing is seeking a Clinical Research & Regulatory Operations Specialist who will oversee complex regulatory and operational aspects of clinical trials at Genesis HealthCare System. This role requires independent coordination of regulatory submissions, contract management, and compliance oversight.

The ideal candidate should possess a strong understanding of legal standards, excellent project management skills, and experience in coordinating contracts. This position plays a critical role in ensuring the integrity of clinical research and patient safety across the health system.

Qualifications

• Experience in legal, compliance, contracts, or regulatory support roles.
• Strong working knowledge of documentation standards and confidentiality.
• Excellent organizational skills with the ability to manage multiple priorities.

Responsibilities

• Coordinate drug and device research protocols ensuring operational readiness.
• Manage contract workflows coordinating with IRB, Compliance, and Finance.
• Prepare regulatory documentation for audits and inspections.

Skills

Legal and regulatory concepts

Project management

Communication skills

Education

Completion of a paralegal or legal studies program

Associate’s degree in a related field

Tools

Standard office software

Document management systems

Job description

Healthcare Staffing is seeking a Clinical Research & Regulatory Operations Specialist who will oversee complex regulatory and operational aspects of clinical trials at Genesis HealthCare System. This role requires independent coordination of regulatory submissions, contract management, and compliance oversight.

The ideal candidate should possess a strong understanding of legal standards, excellent project management skills, and experience in coordinating contracts. This position plays a critical role in ensuring the integrity of clinical research and patient safety across the health system.