Join our dynamic team as an Entry-Level Clinical Research Associate! In this role, you will play a vital part in supporting various clinical trials, collaborating closely with the clinical study team to ensure the success of our research endeavors. Key Responsibilities: Assist in designing and preparing clinical protocols and case report forms. Generate clinical Standard Operating Procedures (SOPs), policies, charters, and plans in line with both U.S. and international regulations. Evaluate potential clinical sites based on established criteria. Support the procurement of budgets, contracts, and necessary regulatory documents related to clinical research. Conduct study initiation visits, facilitating the shipment of clinical supplies and other important materials. Perform ongoing monitoring of studies, including regular site visits to check protocol adherence and inspect study files. Draft comprehensive site visit reports detailing achievements, issues requiring resolution, and recommendations. Conduct study termination visits and gather final reports from investigators, contributing to the preparation of regulatory submissions. Assist in maintaining clinical archives and electronic files. Take on additional tasks as needed to support the team. Requirements: Bachelor's degree (BA, BS, RN, BSN) or equivalent. Basic understanding of Good Clinical Practices (GCP). 1-2 years of clinical research or related experience/training. Exceptional attention to detail and the ability to manage multiple tasks. High integrity and adherence to ethical standards. Excellent written and verbal communication skills. Self-motivated, assertive, and driven to succeed. We offer a comprehensive benefits package, including dental, medical, vision, PTO, and 401k. Ready to make a difference in clinical research? Apply today! Allen Spolden
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