Clinical Research & IRB Specialist

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Overview

GENESIS HEALTHCARE SYSTEM In order to fill our Mission of serving our community by helping each person achieve optimal health and well-being by providing compassionate, exceptional,

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In order to fill our Mission of serving our community by helping each person achieve optimal health and well-being by providing compassionate, exceptional, and affordable healthcare services, all employees of Genesis HealthCare System must be committed to living the Genesis Mission and Genesis values of Compassion, Excellence, Integrity, Team, and Innovation. All employees must regard themselves as an ‘owner’ of Genesis and keep our patients at the center of everything we do - always.

Work Shift:

Day Shift (United States of America)

Scheduled Weekly Hours:

Department:

Institutional Review Board

Overview of 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.

ESSENTIAL DUTIES
Clinical Research Trial Operations – Cancer and Pharmacy
•   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.