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

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!