Clinical Research Coordinator -Cellular Therapy and Transplant Section (CTTS)

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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.

CHOP's Commitment to Diversity, Equity, and Inclusion

CHOP 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
The CHOP Cellular Therapy and Transplant Section (CTTS) is seeking candidates with relevant experience to join its Clinical Research Team. This is an exciting area of growth in CTTS @ CHOP which is one of the most active pediatric cell therapy programs in the world. This is a full-time position located in Philadelphia, PA, USA.

The successful candidate will be joining a team that implements outstanding cutting edge clinical, translational and outcomes research while providing outstanding clinical care to the patients we serve. Areas of research include CAR-T, and other cell and gene therapies. Your work will directly impact how we treat children with various cancers and other devastating diseases!

We offer a unique and exciting multi-disciplinary environment in which to work. Applicants for this position must have demonstrated excellent qualifications, be able to work independently, be flexible and want to work in a team. You can learn more about CTTS at: https://www.chop.edu/centers-programs/cellular-therapy-and-transplant-section

What you will do

• Core responsibilities
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Must comply with federal, state, and sponsor policies
• Related responsibilities
• Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
• Register study on ClinicalTrial.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitate study close out activities as appropriate
• Coordinate research/project team meetings
• Collect, process and ship laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Additional Responsibilities may include
• Manage study finances including sponsor invoicing & resolving study subject billing issues
• Develop advertisement materials
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Organize and/or run study-related meetings locally or across teams (for multi-site projects)
• Support study team communications and outreach
• Provide training to junior staff on conduct of research studies
• Document investigational product (drug/device) accountability
• Self-monitor and self-audit responsibilities
• Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
• Maintain Clinical Trial.gov
• Develop Case Report Forms
• Assignments to include more complex studies

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in a related field Preferred

Experience Qualifications

• At least two (2) years of clinical/research coordination experience Required
• At least three (3) years of clinical/research coordination experience Preferred

Skills and Abilities

• Basic knowledge of IRB and human subject protection
• Excellent verbal and written communications skills
• Strong time management skills
• Ability to collaborate with stakeholders at all levels

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 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.

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