The IRB Analyst III is responsible for coordinating IRB Office processes and/or team(s) of IRB staff made up of IRB Analysts I and II, and clerical support with the purpose of facilitating efficient and accurate processing of IRB submissions. The IRB Analyst III may also perform quality assurance activities on elements of the work flow processes. This position works closely with the Chair CPHS, the IRB Chairs and Vice Chairs and reports to the Assistant Director, IRB Operations. Additionally, the Analyst III position will provide support in the IRB Office by performing tasks within the submission workflow as described below.
Through these activities, the Analyst III helps to ensure that the Hospital’s clinical research activities are 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.
Team Leader: The Analyst III will work with one or more teams of Analysts and clerical staff to coordinate the following functions:
Perform Quality Assurance Reviews of Analysts II’s work and provides constructive feedback.
Perform Quality Assurance Reviews of Analysts I’s work and provides constructive feedback.
Assists on special projects as needed.
Lead institutional research educational activities related to IRB expertise and human subjects protections.
Assist the Director and Chair CPHS in developing, maintaining and updating all applicable SOPs.
Represent the Office in relevant forums in the Hospital.
Represent IRB Office in professional meetings, as appropriate and necessary.
Design and maintenance of IRB electronic management system.
Serve as electronic “Super-user”, corresponds with developers regarding updates and helps train IRB staff on system patches and maintenance.
Assist in training of new IRB office personnel.
Human Subjects Protection: Compliance and Oversight
Ensure that membership of the IRB membership meets IRB SOP requirements, assist in the identification, recruitment and appointment of new members.
Activities related to maintaining IRB AAHRPP accreditation.
Assist in the processing of complex compliance concerns.
Help ensure appropriate legal input for IRB activities.
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.
Job Responsibilities (Continued)
IRB Operations: Provide IRB Support by performing the following tasks:
Oversee workflow balance and timelines of processing items across the office.
Triage, assign and re-assign IRB submissions to ensure efficient processing.
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 subjects protections and IRB operations.
Maintain and ensure retention of all required IRB records, communications and other documents.
Contacts with others
Develop and maintain contacts among peers at other institutions, monitor on-going national discussions on regulatory and ethical issues.
Communicate with federal/state regulatory offices, as appropriate and as required by the Director.
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.
Required Education and Experience
BA/BS degree (biology, psychology or other clinical research-related area) required; equivalent combination of experience and education will be considered.
Minimum of 7 years of experience in IRB administration, clinical research or other humans subjects protection-related job. Direct and obvious relevance to regulatory compliance and research with human subjects
Preferred Education, Experience & Cert/Lic
Preferred Education: Masters degree.
Additional Technical Requirements
Skills and knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators
Knowledge of clinical research and familiarity with medical terminology
Ability to 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.
Excellent written and oral communications skills.
Ability to provide effective leadership to work group.
Demonstrated ability to work as a team member
Ability to work effectively with individuals at all levels of the organization.
Excellent time management skills with ability to independently prioritize, organize and efficiently deal with a multiple ongoing activities
Must be mature, self-motivated and responsible; must be able to initiate and complete routine and non-routine tasks
Familiarity MS Word required; experience with computerized databases and MS Windows operating system environment helpful.
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 or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).
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.
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