Reference #: 1013012
SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren'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.CHOP's Commitment to Diversity, Equity, and InclusionCHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.A Brief Overview
This role supports the day-to-day operations of the IRB Office and provides excellent customer service to the research community, IRB committee members and IRB office staff in the course of daily functions. This role provides support for the electronic IRB (eIRB) functionality, improvements, and maintenance for the IRB office, and facilitates eIRB education and training of the research
community.This role assists the Resource Coordinator 3 (RC3) and/or Clinical Research Program Manager I (CRPM1) in coordinating seminars, scheduling meetings, making travel arrangements and otherwise providing broad support for the IRB, office and investigators in carrying out their research program.In addition, the RC1 serves as an information conduit between the IRB office, IRB committee members, and investigators, sharing information and supporting the submission of materials as requested.What you will do
IRB Operations: Provide IRB Support by Performing the Following Tasks:
Performs general support duties, including but not limited to answering phones, maintaining paper and electronic files, answering email, managing and ordering supplies, placing maintenance requests, creating minutes for office meetings, scheduling committee meetings, and assisting RC3 and/or CRPM1 with the submission of required information.
Provides support to the IRB committees and IRB staff, including but not limited to maintaining IRB member files, organizing travel, and scheduling meetings.
Conducts administrative reviews of IRB submissions applying basic regulatory knowledge
eIRB System Maintenance & Training
Provides support for the eIRB system functionality, improvements, and maintenance for the IRB office, including identifying, logging, and testing eIRB issues.
Maintains technical specification documentation for eIRB developers and IRB office staff to ensure required functionality meets the stakeholders' needs related to submitting and reviewing human subjects research.
Assist in managing communications between the IRB office, eResearch Developers/Project Managers, and the research community concerning changes to eIRB.
Assists study team members with eIRB and with the IRB submission process, either via phone or email.
Coordination with others:
Responds to inquiries from both within and outside the Hospital and from both faculty and administrators regarding IRB SOPs, function, organization, training, etc.
Develops and maintain relationships among peers and other institutions
Helps to support audits to manage risk through internal collaboration
Additional Duties:
Assists in updating and maintaining the IRB internet site.
Provides support, including assisting with document preparation, document tracking, and interviewee scheduling, of Accreditation of Human Research Protections Programs (AAHRPP) and FDA site visits.
Performs other dut es and assists on special projects as assigned.
Education Qualifications
High School Diploma / GED Required
Bachelor's Degree Preferred
Experience Qualifications
At least one (1) year of research, coordination or administrative experience Required
At least three (3) years of research, coordination or administrative experience Preferred
Previous experience in a healthcare-related environment Preferred
Previous experience working with IRB Preferred
Skills and Abilities
Excellent verbal and written communications skills, including ability to interact appropriately with Principal Investigators, study coordinators, research administration staff members, CHOP leadership, study participants' families, IRB committee members, and staff
Excellent interpersonal skills, including providing excellent customer service to both external and internal customers
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 support collaborative efforts
Ability to quickly grasp and learn new concepts and procedures
Excellent time management skills, particularly ensuring deadlines are met in a high-volume, fast-paced environment
Excellent organizational and prioritization skills
Ability to work both independently and as part of a team
Intermediate proficiency with office, including word processing (Microsoft Word), spreadsheet (Excel), and PowerPoint. IRB system experience such as Click Commerce Software and FileMaker Pro preferredTo 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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.EEO / VEVRAA Federal Contractor | Tobacco StatementChildren'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.
