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

Children's Hospital of Philadelphia - Philadelphia, PA

Full-time - Entry Level

Philadelphia, PA

10,001+ employees

Hospitals

About the position

Children's Hospital of Philadelphia (CHOP) is seeking candidates with relevant experience to join its Clinical Research Team in the Cellular Therapy and Transplant Section (CTTS). This is a full-time position located in Philadelphia, PA, USA, and is part of one of the most active pediatric cell therapy programs in the world. The successful candidate will be involved in cutting-edge clinical, translational, and outcomes research while providing outstanding clinical care to patients. Research areas include CAR-T and other cell and gene therapies, directly impacting the treatment of children with various cancers and other devastating diseases.

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
• Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.)
• 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
• 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

Requirements

• Bachelor's Degree Required
• At least two (2) years of clinical/research coordination experience Required
• 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

Nice-to-haves

• Master's Degree in a related field Preferred
• At least three (3) years of clinical/research coordination experience Preferred