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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, 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.
Position Details:
Work Shift:
Day Shift (United States of America)
Scheduled Weekly Hours:
40
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.
Contract, Budget, and Financial Oversight
• 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.
FDA and Regulatory Compliance
• 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.
Education, Collaboration, and Special Projects
• 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.
IRB and Human Subjects Regulatory Oversight
• 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.
QUALIFICATIONS
1. Completion of a paralegal or legal studies program or associate's degree in a related field.
2. Progressively responsible experience in legal, compliance, contracts, or regulatory support roles.
3. Demonstrated experience reviewing, drafting, and coordinating contracts or other formal agreements.
4. Proven ability to serve as a subject matter resource and to provide guidance, training, or oversight to other staff.
5. Strong working knowledge of legal and regulatory concepts, including documentation standards, confidentiality, and compliance requirements.
6. Excellent organizational, project management, and communication skills, with the ability to manage multiple complex priorities.
7. High level of professionalism, sound judgment, and discretion in handling sensitive and confidential information.
8. Proficiency with standard office software and the ability to effectively use or learn electronic filing, specialized research and document management systems.
PATIENT CENTERED CARE & BEHAVIORAL EXPECTATIONS
1. Living the Genesis Mission, Vision and Values
• Performs work in a manner that is quality focused.
• Treats patients, co-workers, visitors and volunteers with courtesy, compassion, empathy and respect.
• Results oriented and focused on achievement of objectives.
• Acknowledges and responds to the diversity of people and the situation.
• Encourages peers (others) to be owners of change.
• Always makes the effort to anticipate and exceed customer needs and expectations.
• Possesses the ability to engage others with patience and understanding.
• Acts in a manner that creates positive first and lasting impressions.
• Demonstrates the ability to own issues until they are resolved.
2. Patient Centered Care (patients/families, physicians, co-workers, all other internal/external customers)
• Introduces self and role...connects with everyone.
• Communicates effectively (i.e. advising others of actions, pertinent information, time durations, etc.) and asks for feedback.
• Asks for and anticipates needs and concerns of others.
• Maintains a positive work environment for staff and a healing environment for patients (i.e. safe, clean, quiet, etc.)
• Maintains the dignity and privacy of each person; manages confidential/sensitive information appropriately.
• Responds to requests in an appropriate and timely manner.
• Exits patient/customer encounters courteously, asking if there are additional needs that can be addressed.
3. Promotes Patient and Employee Safety
• Demonstrates safe patient handling (i.e. transfers, transport, care administration, nutrition, medication, etc.).
• Demonstrates safe materials handling (i.e. appropriate use and disposal of chemicals, infectious wastes, etc.).
• Demonstrates appropriate knowledge of Infectious Disease precautions and use of proper protective equipment.
• Demonstrates Slips/Trips and Falls Awareness.
• Actively contributes to maintaining a safe, clean and quiet environment.
WORKING CONDITIONS/PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Works in an office environment.
2. Answers telephone calls, uses a personal computer and other business machines extensively, which requires the ability to apply finger dexterity. Individual bends, reaches, pushes and pulls file drawers to file records and reports.
3. 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.
4. Vision abilities required include up close vision, peripheral vision, depth perception and the ability to adjust focus.
This description reflects in general terms the type and level of work performed. It is not intended to be all-inclusive, nor portray the specific duties of any one incumbent.
Thank you for your interest in employment at Genesis. Genesis is committed to being an equal opportunity employer. Selection of applicants for employment is based only on qualifications and the requirements of a specific job.