Clinical Trial Coordinator I - FSP

Job Title: Clinical Trial Coordinator I - FSP Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. The Clinical Trial Coordinator I (CTC I) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. you may act as a buddy during the onboarding phase and provide training to new staff as needed. Essential Duties & Responsibilities Assists in coordination and administration of clinical studies from the start-up to execution and close-out. Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study. Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study. Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements. Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness". Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports