Clinical Research & IRB Specialist

Clinical Research & Regulatory Operations Specialist

The Clinical Research & Regulatory Operations Specialist serves as a system-level resource supporting both the Institutional Review Board (IRB) and the Clinical Research Department, including Cancer Research and Pharmacy Research, across Genesis HealthCare System. This position independently coordinates complex regulatory, contractual, financial, and operational aspects of clinical trials and IRB activities, functioning with minimal supervision and exercising advanced judgment.

The role oversees Clinical Research Trial contract workflows, supports negotiations, manages regulatory submissions and reporting, and ensures operational readiness and ongoing compliance with FDA regulations, human subjects protections, and institutional requirements. The Specialist functions as a subject matter expert for IRB leadership, investigators, research staff, pharmacy, and clinical departments, and provides high-level operational, regulatory, and compliance support to both research operations and IRB governance.

Essential duties include:

• Coordinates and supports drug, biologic, device, and other interventional research protocols conducted within Cancer Research and Pharmacy Research, ensuring operational readiness across all phases from feasibility through study close out.
• Collaborates with investigators, research nurses, navigators, pharmacy staff, and IRB personnel to ensure IRB approval and ongoing regulatory compliance for oncology, investigational drug, and pharmacy led studies.
• Manages and oversees Clinical Research Trial contract workflows for Cancer Research and Pharmacy Research across the health system, coordinating closely with IRB requirements, Legal Services, Compliance, Finance, and departmental leadership.
• Prepares and maintains regulatory documentation required for FDA or other regulatory agency audits and inspections related to investigational drugs, biologics, and devices, in coordination with both IRB oversight and clinical research operations.
• Develops, delivers, or coordinates training for investigators, research staff, and IRB members related to IRB processes, FDA regulations, GCP requirements, contract and budget fundamentals, and oncology/pharmacy research operations.

Qualifications include:

• Completion of a paralegal or legal studies program or associate's degree in a related field.
• Progressively responsible experience in legal, compliance, contracts, or regulatory support roles.
• Demonstrated experience reviewing, drafting, and coordinating contracts or other formal agreements.
• Strong working knowledge of legal and regulatory concepts, including documentation standards, confidentiality, and compliance requirements.
• Excellent organizational, project management, and communication skills, with the ability to manage multiple complex priorities.
• High level of professionalism, sound judgment, and discretion in handling sensitive and confidential information.
• Proficiency with standard office software and the ability to effectively use or learn electronic filing, specialized research and document management systems.

Patient centered care and behavioral expectations include:

• Living the Genesis Mission, Vision and Values.
• Patient Centered Care.
• Promotes Patient and Employee Safety.

Working conditions/physical requirements include:

• Works in an office environment.
• Answers telephone calls, uses a personal computer and other business machines extensively.
• Regularly lift or move up to 10 pounds, frequently lift or move up to 25 pounds and occasionally lift or move up to 50 pounds.
• Vision abilities required include up close vision, peripheral vision, depth perception and the ability to adjust focus.