Job Description As an Entry-Level Clinical Research Associate, you will play a key role in supporting a range of clinical trials. Under the guidance of your supervisor or a designated mentor, you will assist the clinical study team in various capacities to ensure the success of our research initiatives. Essential Duties and Responsibilities Assist in the design and preparation of study protocols and case report forms. Help generate clinical standard operating procedures (SOPs), policies, and plans in accordance with U.S. and international guidelines. Participate in evaluating potential clinical sites to ensure they meet our acceptance criteria. Manage the procurement of study budgets, contracts, regulatory documents, and other administrative items essential to clinical research. Conduct initiation site visits and arrange the shipment of necessary clinical supplies and documentation. Engage in ongoing study monitoring, which includes regular visits to study sites, adherence checks to protocols, and management of study files. Compile site visit reports that highlight key achievements, issues needing attention, and suggest follow-up actions for assigned study sites. Conduct study termination visits, gather final reports from investigators, and assist in preparing final reports for regulatory submission. Help maintain the clinical archive and electronic files essential for research compliance. Perform additional tasks as needed to support the clinical research team. Requirements Bachelor’s degree in a relevant field (BA, BS, RN, BSN, or equivalent). Basic knowledge of Good Clinical Practices (GCPs). 1-2 years of experience in clinical research or equivalent training. Exceptional attention to detail and accuracy. Ability to handle multiple tasks simultaneously and efficiently. Strong commitment to integrity and ethical standards. Excellent written and verbal communication skills. Self-motivated, proactive, and goal-driven. Benefits Comprehensive benefits package including dental, medical, vision insurance, paid time off (PTO), and a 401K plan. ALLEN SPOLDEN
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