Clinical Research Coordinator I - Rheumatology

About the role

The Division of Rheumatology at the Children’s Hospital of Philadelphia is seeking an experienced Clinical Research Coordinator to join their team. This position supports IND and IDE studies, clinical trial management, patient recruitment, and onboarding support.

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
• Care for protocol related research procedures, study visits, and follow-up care
• Screens, recruits, and enrolls patients/research participants
• Maintains study source documents
• Reports adverse events
• Understands good clinical practice (GCP) and regulatory compliance
• Edits subjects and family on protocol, study intervention, etc.
• Complies with Institutional policies, standard operating procedures (SOPs), and guidelines, and with HIPAA and management of confidential materials
• Complies with federal, state, and sponsor policies
• Supports communication and meeting scheduling across teams for multi-site studies or collaborations
• Manages essential regulatory documents
• Completes case report forms (paper & electronic data capture)
• Submits documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
• Facilitates pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitates study close out activities as appropriate
• Coordinates research/project team meetings
• Collects, processes, and ships samples as applicable to the protocol
• Schedules subject visits and procedures
• Retains records/archive documents after study close out

Qualifications

• A high school diploma/GED is required
• A bachelor's degree is preferred
• At least two (2) years of clinical or research related experience is required
• At least three (3) years of clinical or research related experience is preferred

Skills and Abilities

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