Coordinates all clinical research activities within the scope of clinical research protocols. 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
AA/AAS in a related field. 3+ year(s) relevant clinical research experience
Clin Research Coordinator I Date: Aug 8, 2017 Location: Philadelphia, PA, US, 19104 Company: CHOP Apply now » Job Description Req ID: 12694 Shift: Days 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 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 Preferred Education: BA/BS in a related field Preferred Experience: 2 year(s) relevant clinical research experience Experience with literature reviews, scientific writing helpful. Must have good organizational skills and time management. Must be able to work collaboratively in a team. General understanding of statistics and computer logic necessary. Any experience with website development also helpful. Additional Technical Requirements Requires effective writing and communication, work as part of a team, ability to multitask Nearest Major Market: Philadelphia Job Segment: Clinical Research, Medical Research, Research, Healthcare Apply now »
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