IRB Analyst II

Children’s Hospital of Philadelphia•Philadelphia, PA

2d•$69,200 - $88,200•Onsite

About The Position

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 for conducting complex and expedited reviews, assisting other team members and other support staff, and consulting to clinical investigators at CHOP. 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.

Requirements

Bachelor's Degree Required
At least four (4) years of IRB administration, clinical research or human subject protection, regulatory compliance or research related experience Required
Advanced knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators
Intermediate knowledge of clinical research
Intermediate knowledge of medical terminology
Advanced proficiency with office software (Microsoft Office) including word processing and spreadsheet software (Word, Excel)
Advanced proficiency with database software
Excellent verbal and written communications skills
Strong time management skills
Strong organizational skills
Solid leadership 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

Nice To Haves

Master's Degree in biology, psychology or other clinical research-related area Preferred
At least six (6) years of IRB administration, clinical research or human subject protection, regulatory compliance or research related experience Preferred
Certified IRB Professional (CIP) - Public Responsibility in Medicine and Research (PRIM&R) - upon hire - Preferred

Responsibilities

Assist in the processing of complex compliance concerns.
Maintain a current understanding and knowledge of federal and state regulations, state and local law, and CHOP IRB SOPs.
Serve as a consultant to the IRB membership and the institution on matters related to IRB procedures and applicable federal regulations.
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.
Perform IRB reviews as a designee of the IRB chair.
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.
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.
Perform Quality Assurance Reviews of team members' work and provides constructive feedback.
Assists on special projects as needed.
Lead institutional research educational activities related to IRB expertise and human subjects protections.
Represent the Office in relevant forums in the Hospital.
Design and maintenance of IRB electronic management system.
Assist in training of new IRB office personnel.