IRB Analyst I

Philadelphia, PA, US, 19104

Location: LOC_HOME-Home/Remote Office Location 

Req ID: 138277

Shift: Days

Employment Status: Regular - Full Time 

Job Summary

This role is responsible for staffing the Committee for the Protection of Human Subjects (CPHS) and its Institutional Review Boards (IRB). They help ensure that the IRB’s work is accomplished in a timely manner.


This role works closely with the Chair CPHS, the IRB Chairs and Vice Chairs and reports to directly to the Assistant Director, IRB Operations or IRB Operations Supervisor.


This role will help ensure that the Hospital’s clinical research activities are conducted in compliance with institutional SOPs and international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research. They ensure that research activities at the Hospital involving human subjects are conducted in a manner that protects the safety, rights, and welfare of participants.


Due to Covid-19 precautions, this role will be working remotely at this time. In-office hours will likely be required as pandemic restrictions ease and corresponding CHOP guidelines allow.

Job Responsibilities

1. Human Subjects Protection: Compliance and Oversight
• Maintain a current understanding and knowledge of federal and state regulations, state and local law, and CHOP IRB SOPs.
• Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects.
• Interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies for discussion with the Committee and/or Committee Chair. 


2. IRB Operations: Provide IRB Support:
• Responsible for the ensuring timely processing, pre-review and disposition of assigned protocols, modifications, continuing reviews, unanticipated problems involving risks to subjects or others, and investigator responses.
• Perform screening/review of submitted protocols to ensure completeness and conformance with IRB SOPs.
• Prepare agenda and minutes for committee meetings in accordance with SOPs.
• Work closely with, and in support of, the respective IRB Chair, Vice Chairs, reviewers and other members.
• Participate in all relevant institutional research educational activities related to human subject protections and IRB operations.
• Maintain and ensure retention of all required IRB records, communications and other documents.


3. Collaborate on related matters
• Assist in the coordination of IRB activities with other CHOP Divisions and Departments.
• Provide education and training on use of IRB electronic management system with the research community.
• Timely communication with investigators/designees regarding IRB submissions.


Assist with special projects as needed.

Job Responsibilities (Continued)

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

Required Education and Experience

Required Education: Bachelor’s degree


Required Experience: One (1) year of experience in IRB administration, clinical research or human subject protection, regulatory compliance or research related job.

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in biology, psychology or other clinical research-related area


Preferred Experience: Three (3) years of experience in IRB administration, clinical research or human subject protection, regulatory compliance or research related job.

Additional Technical Requirements

• Intermediate knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators
• Basic knowledge of clinical research
• Basic knowledge of medical terminology
• Intermediate proficiency with office software (Microsoft Office) including word processing and spreadsheet software (Word, Excel)
• Intermediate proficiency with database software
• Strong verbal and written communications skills
• Solid time management skills
• Solid organizational skills
• Ability to gather, analyze and make recommendations/decisions based on data
• Ability to convey complex or technical information in an easy to understand manner
• Ability to maintain confidentiality and professionalism
• Ability to work independently with minimal supervision
• Ability to collaborate with stakeholders at all levels
• Ability to be flexible and adaptable to change 

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products.

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.  Please contact our hiring official with any referrals or questions.

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Philadelphia, PA 19146 




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