IRB Analyst II

SHIFT:

Day (United States of America)

Seeking Breakthrough Makers

Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career.

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A Brief Overview 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.

What you will do

• Human Subjects Protection: Compliance and Oversight
• 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.
• IRB Operations: Provide IRB Support:
• 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.
• Collaborate on related matters
• Assist in the processing of complex compliance concerns.
• Assist in the coordination of IRB activities with other CHOP Divisions and Departments.
• 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.
• 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.

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in biology, psychology or other clinical research-related area Preferred

Experience Qualifications

• At least four (4) years of IRB administration, clinical research or human subject protection, regulatory compliance or research related experience Required
• At least six (6) years of IRB administration, clinical research or human subject protection, regulatory compliance or research related experience Preferred

Skills and Abilities

• 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

Licenses and Certifications

• Certified IRB Professional (CIP) - Public Responsibility in Medicine and Research (PRIM&R) - upon hire - Preferred

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

$69,200.00 - $88,200.00 Annually

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.