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The Children's Hospital of Philadelphia Clinical Research Coordinator II in Philadelphia, Pennsylvania

COLKET - Colket Translational Research Req ID: 29130.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Shift: Days.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Employment Status: AF - Active - Regular - Full Time.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; JOB SUMMARY.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; The Clinical Research Coordinator II position will primarily be responsible for all aspects of study coordination for designated studies conducted within the Division of Oncology..and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Responsible for the coordination of clinical research trials and other studies as assigned within the Neuro-Oncology section in the Division of Oncology..and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Assist in keeping relevant protocol and patient information updated in the Oncology Research Clinical Trial Management System..and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Participate in research team meetings, division-wide coordinator meetings and continued education and training within the CHOP Research Institute related to this role..and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Expected to attend trainings on good clinical practices (GCP) and research related regulations and responsibilities within the institution and will be held accountable for adherence to all policies and procedures surrounding this process and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources..and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; JOB RESPONSIBILITIES.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Core responsibilities.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Adhere to an IRB approved protocol.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Participate in the informed consent process of study subjects.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Support the safety of clinical research patients/research participants.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Coordinate protocol related research procedures, study visits, and follow-up care.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Screen, recruit and enroll patients/research participants.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Maintain study source documents.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Report adverse events.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Understand good clinical practice (GCP) and regulatory compliance.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Educate subjects and family on protocol, study intervention, etc..and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Comply with Institutional policies, standard operating procedures (SOPs) and guidelines.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Must comply with federal, state, and sponsor policies.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Related responsibilities.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Manage essential regulatory documents.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Register study on ClinicalTrial.gov.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Complete case report forms (paper .and.amp; electronic data capture) and address queries.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer).and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Facilitate pre-study, site qualification, study initiation, and monitoring visit.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Facilitate study close out activities.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Coordinate research/project team meetings.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Collect, process and ship laboratory specimens.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Schedule subject visits and procedures.and.nbsp;.and.

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