Clinical Research & IRB Specialist

Genesis Healthcare System•Oak Park, IL

3d•Onsite

About The Position

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.

Requirements

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.
Proven ability to serve as a subject matter resource and to provide guidance, training, or oversight to other staff.
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.

Responsibilities

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.
Oversees and documents the informed consent process as appropriate, confirming signed informed consent is obtained prior to any study specific procedures, and that consent forms reflect current IRB approved language.
Maintains complete and current regulatory binders, Trial Master File (TMF) components, and site files in accordance with sponsor, FDA, IRB, and institutional requirements.
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 documentation and supports audit readiness for sponsor, CRO, internal, and external audits or inspections (including FDA), ensuring contracts, IRB records, regulatory files, and financial documentation are complete and inspection ready.
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.
Supports compliance obligations including ClinicalTrials.gov registration and results reporting, aligning IRB determinations with federal and sponsor requirements.
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.
Leads or participates in special projects at the direction of the IRB Chair, Director of Clinical Research, or other senior leaders, including quality improvement initiatives, process redesign, and research program growth.
Provides direct operational and regulatory support to the IRB, including protocol review, IRB submissions, agenda preparation, meeting minutes, regulatory tracking, and investigator guidance.
Ensures alignment between IRB determinations and Clinical Research Department operations, supporting compliant and efficient study activation and conduct across the health system.