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

Req ID: 25097.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Shift: Any.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; JOB SUMMARY.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Under minimal supervision, coordinates all clinical research activities within the scope of clinical research protocols..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.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Retain records/archive documents after study close out.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Also may be responsible for any of the following:.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Manage study finances including sponsor invoicing .and.amp; resolving study subject billing issues.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Develop advertisement materials.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Document investigational product (drug/device) accountability.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Self-monitor and self-audit responsibilities.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Develop informed consent document.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Maintain Clinical Trial.gov.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Develop Case Report Forms.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; * Assignments to include more complex studies.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; JOB RESPONSIBILITIES (CONTINUED).and.nbsp;.and.nbsp;.and.nbsp;.and.nb

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