The Children's Hospital of Philadelphia Clin Research Coordinator I in Philadelphia, Pennsylvania

Req ID: 18882 Shift: Any Employment Status: AF - Active - Regular - Full Time JOB SUMMARY Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols. JOB RESPONSIBILITIES The CRC I is expected to perform all CRC Core responsibilities (as applicable): * 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. Also may be responsible for any of the following: * Manage essential regulatory documents * Register study on ClinicalTrial.gov * Complete case report forms (paper & electronic data capture) and address queries * Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer) * Facilitate pre-study, site qualification, study initiation, and monitoring visits * Facilitate study close out activities * Coordinate research/project team meetings * Collect, process and ship laboratory specimens * Schedule subject visits and procedures * Retain records/archive documents after study close out JOB RESPONSIBILITIES (CONTINUED) JOB RESPONSIBILITIES (CONTINUED) REQUIRED LICENSES, CERTIFICATIONS, REGISTRATIONS REQUIRED EDUCATION AND EXPERIENCE Required Education:: AA/AAS in a related field Required Experience: 3+ year(s) relevant clinical research experience PREFERRED EDUCATION, EXPERIENCE & CERT/LIC