IRB Analyst I

Children's Hospital of Philadelphia

1d•$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 IRB work is completed in a timely manner. The position works closely with the CPHS Chair, IRB Chairs and Vice Chairs, and reports directly to the Assistant Director, IRB Operations or IRB Operations Supervisor. The role supports compliance with institutional standard operating procedures and applicable international, federal, state, and local regulations and ethical principles for research involving human subjects. It helps ensure research activities protect participants’ safety, rights, and welfare. The analyst reviews and processes research submissions, supports committee meetings, maintains IRB records, communicates with investigators, and coordinates with other CHOP departments. The role also provides education and training on the IRB electronic management system and contributes to related projects.

Requirements

Bachelor’s degree required.
At least one year of IRB administration, clinical research, human-subject protection, regulatory compliance, or research-related experience required.
Intermediate knowledge of federal regulations pertaining to research, 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 data and make recommendations or decisions based on it.
Ability to convey 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 preferred.
At least three years of IRB administration, clinical research, human-subject protection, regulatory compliance, or research-related experience preferred.

Responsibilities

Maintain current knowledge of federal and state regulations, state and local law, and CHOP IRB standard operating procedures.
Participate in continuing education and relevant 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 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 standard operating procedures.
Prepare committee meeting agendas and minutes in accordance with standard operating procedures.
Work with and support the respective IRB Chair, Vice Chairs, reviewers, and other members.
Participate in institutional research education activities related to human-subject protections and IRB operations.
Maintain and ensure retention of required IRB records, communications, and other documents.
Coordinate IRB activities with other CHOP divisions and departments.
Provide education and training to the research community on use of the IRB electronic management system.
Communicate promptly with investigators and designees regarding IRB submissions.
Assist with special projects as needed.