IRB Analyst I

Children’s Hospital of Philadelphia • Philadelphia, PA

4h • $62,900 - $80,200

About The Position

The IRB Analyst I staffs the Committee for the Protection of Human Subjects (CPHS) and its Institutional Review Boards (IRBs), helping ensure that IRB work is completed in a timely manner. The role works closely with the CPHS Chair, IRB Chairs and Vice Chairs, and reports to the Assistant Director, IRB Operations or IRB Operations Supervisor. It helps ensure that the Hospital’s clinical research activities comply with institutional SOPs; international, federal, state, and local rules and regulations; and ethical principles for human-subject research. The position supports research practices that protect the safety, rights, and welfare of participants.

The analyst maintains knowledge of applicable regulations and policies, reviews research protocols against guidelines and internal requirements, and makes recommendations or decisions for discussion with the Committee or Committee Chair. The role processes and reviews assigned submissions, supports committee meetings, maintains required records, and communicates with investigators. It also coordinates with other CHOP divisions and departments, provides training on the IRB electronic management system, and assists with special projects.

Requirements

• Bachelor's degree.
• At least one year of experience in IRB administration, clinical research, human-subject protection, regulatory compliance, or a related research area.
• Intermediate knowledge of federal research regulations, ICH GCP, and HIPAA sufficient to function independently as a consultant to clinical investigators.
• Basic knowledge of clinical research and medical terminology.
• Intermediate proficiency with Microsoft Office, including word-processing and spreadsheet software such as Word and Excel.
• Intermediate proficiency with database software.
• Strong verbal and written communication skills.
• Solid time-management and organizational skills.
• Ability to gather and analyze information and make recommendations or decisions based on data.
• Ability to explain complex or technical information clearly.
• 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.

Nice To Haves

• Master's degree in biology, psychology, or another clinical research-related area.
• At least three years of experience in IRB administration, clinical research, human-subject protection, regulatory compliance, or a related research area.

Responsibilities

• Maintain current knowledge of federal and state regulations, state and local laws, and CHOP IRB SOPs.
• Participate in continuing education and national or regional organizations focused on research ethics and human-subject protection.
• Interpret research protocol information in relation to federal guidelines and internal policies, and exercise judgment to make recommendations or decisions for discussion with the Committee or Committee Chair.
• Ensure timely processing, pre-review, and disposition of assigned protocols, modifications, continuing reviews, unanticipated problems involving risks to subjects or others, and investigator responses.
• Screen and review submitted protocols for completeness and conformance with IRB SOPs.
• Prepare agendas and minutes for committee meetings in accordance with SOPs.
• Work with and support the relevant IRB Chair, Vice Chairs, reviewers, and other committee members.
• Participate in institutional educational activities related to human-subject protections and IRB operations.
• Maintain and ensure retention of required IRB records, communications, and other documents.
• Assist in coordinating IRB activities with other CHOP divisions and departments.
• Provide education and training to the research community on the IRB electronic management system.
• Communicate in a timely manner with investigators and designees regarding IRB submissions.
• Assist with special projects as needed.

Benefits

• Annual influenza vaccination is required as a condition of employment for employees working in patient-care buildings or with patient-facing responsibilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level