IRB Consultant
Job Posting for IRB Consultant at Genesis HealthCare System
GENESIS HEALTHCARE SYSTEM
In order to fulfill our Mission of providing Compassionate, Quality HealthCare, all employees of Genesis HealthCare System must be committed to living the Genesis Mission and Genesis values of Compassion, Trust, Innovation, and Excellence. All employees must regard themselves as an "owner" of Genesis and keep our patients at the center of everything we do - always .
Position Details :
DAY SHIFT MONDAY - FRIDAY
PT2 20-29 BENEFITS. FTE: 0.500000
Genesis Hospital - Maple Campus
Overview of position:
Summary:
This position is responsible for reviewing all submissions to the Institutional Review Board (IRB) to ensure that IRB members have all the requisite information to review human subject research; enabling the IRB board members, including the IRB Chair, to perform their review tasks by providing the necessary documents and education; acting as facilitator between researchers and other involved institutions.
Essential Duties:
Responsibilities:
- Reviews complex scientific research protocol documents and identifies regulatory issues and communicates those issues to the IRB Chair, members and study staff with the goal of resolution.
- Reviews all applications to the IRB, including informed consent, to determine completeness and consistency with federal guidelines and institutional requirements.
- Prepares items for review by IRB Chair, and obtains any needed information and material.
- Determines and compiles meeting agendas to meet distribution deadline, disseminates meeting agendas and packets, coordinates and attends meetings.
- Records the minutes and decision making process of the IRB, including members present or absent from meetings as well as alternates; details on discussions, particularly controverted issues and their resolution; and votes on actions, including those who abstain or absent themselves due to conflict of interest; and all other details associated with the decision making process of the IRB.
- Provides guidance and training to investigators and research staff regarding procedural requirements for submission to the IRB.
- Interfaces with other departments and other institutions, including problem-solving at institutional levels in addition to the individual investigator level.
- Verifies that appropriate documentation is obtained before final IRB approval is issued, including ensuring presence of education requirements for all study staff, required documentation for all external performance sites, and required documentation for investigational drug or device numbers.
- Assists with revisions and implementation of IRB forms, policies and procedures, as well as other resources for the research community.
- Ensures that protocols undergo continuing review within current approval period and issues expiration letters for those whose approval lapses.
- Communicates results of IRB reviews to Principle Investigator and drafts other correspondence as needed in an organized, clear, concise manner.
- Interacts positively with research participants, and the research community, and appropriately addresses issues, including complaints.
- Maintains and audits IRB records and files.
- Gathers information and material in response to inquiries, and responds to requests for information regarding IRB review.
- Assists in identifying areas of focus for education topics.
- Prepares IRB annual report.
- Assists in arranging accommodations for site visitors and guest speakers.
- Participates in required human subject training.
- Extrapolates requirements from regulation and IRB policies and procedures to guide the research community members, while communicating detailed information with brevity.
- Leads special projects as assigned by IRB Chair, and completes other work as assigned.
Minimum Qualifications:
Other information:
- Associates Degree in a healthcare related field or 5 years of IRB experience/regulatory compliance, or a combination of the two.
- Knowledge of human subjects regulatory compliance.
- Excellent interpersonal, decision-making, analytical skills, conflict resolution and investigative skills.
- Ability to work independently and under pressure in a complex and changing working environment.
- Excellent computer skills and knowledge of computer software, including programs such as Microsoft Office.
Patient Centered Care & Behavioral Expectations at Genesis HealthCare System:
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 :
T he physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Working conditions:
Essential:
Essential:
- No exposure to blood, body fluids, or tissues.
- Works in an office environment.
- Ability to lift 10 pounds to waist level.
- Ability to sit, stand, push, pull, bend, and squat.
- Ability to climb, balance, stoop, kneel, crouch or crawl.
- Ability to sit for extended periods of time.
- Close up and peripheral vision abilities.
Th is 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.
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