Entry-Level Clinical Research Associate - ALLEN SPOLDEN : Job Details

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.