Job Description

We are seeking a dedicated Clinical Research Associate to join our dynamic clinical study team. In this role, you will play a vital part in supporting clinical trials and ensuring successful study execution under the guidance of your supervisor. Key Responsibilities: Assist in the design and preparation of clinical study protocols and case report forms. Create clinical Standard Operating Procedures (SOPs), policies, charters, and plans in compliance with US and international regulations. Evaluate potential clinical sites based on established criteria for acceptability. Manage the procurement of budgets, contracts, and necessary regulatory documents for clinical research activities. Initiate studies by performing site visits, coordinating the shipment of clinical supplies, and preparing materials. Conduct regular monitoring of studies through site visits, ensuring protocol adherence, inspecting study files, and managing related tasks. Prepare detailed site visit reports highlighting key achievements, issues needing resolution, and recommendations for follow-up actions. Conduct study termination visits, gather final reports from investigators, and aid in the preparation of regulatory submission reports. Assist in maintaining clinical archives and electronic documentation. Complete additional tasks as assigned to support the clinical research efforts. Qualifications: Bachelor's degree (BA, BS, RN, BSN) or equivalent experience. Fundamental knowledge of Good Clinical Practices (GCPs). 1-2 years of relevant clinical research experience or equivalent training. Strong attention to detail and commitment to high-quality work. Ability to effectively manage multiple tasks simultaneously. Demonstrate integrity and adhere to the highest ethical standards. Excellent written and verbal communication skills. Self-motivated, assertive, and driven to succeed. Benefits: We offer comprehensive benefits including dental, medical, vision, and 401K plans. Allen Spolden

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