The Department of Neurology is recruiting a Clinical Research Coordinator A to support the Center for Neuroengineering and Therapeutics (CNT) in investigator-sponsored and clinical trials research in epilepsy. The primary responsibility of the coordinator will be managing all regulatory aspects of the CNT protocols, subject tracking and communicating subject information and data to research groups, and collecting and maintaining all of the subjects’ clinical data abstracted from primary medical records.
With minimal supervision, this coordinator will be primary responsible for: 1) preparation and processing of all Institutional Review Board (IRB) documentation through the IRB and defined regulatory authorities, including initial submissions, continuing reviews, amendments, consent form drafting, and adverse event reporting. 2) subject data tracking, subject consenting, and facilitating communication among various coordinators and collaborating research teams to ensure the integrity of the protocols is maintained and that all clinical data queries are answered in a timely manner. S/he will be responsible for working independently with external group staff to find the datasets appropriate for studies and harmonizing the data. 3) maintaining our primarily observational research database (REDCap) of clinical data abstracted from primary medical records. This includes collecting, entering, organizing, and maintaining all documentation required including source documentation, case report forms, and research charts. CRC will assure the accuracy of all study documentation, personnel documentation, and recruitment logs. CRC will oversee compliance and access with respect to HIPAA and applicable CFR, and will contribute to process improvement and development of SOPs and case report forms. This requires an understanding and interpretation of data arising from observational research studies. 4) participating in study team meetings, attending surgical case conference at Penn and CHOP, and engaging in ongoing protocol training/compliance meetings. CRC will assist in the monitoring of external sites and the management of multisite trials while adhering to all University of Pennsylvania, FDA and GCP guidelines. 5) seeking guidance when faced with challenges and actively serving as backup support for other CNT CRCs 6) engaging in administrative activity as needed and performing other duties as assigned
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