Job Description

Important information:

Clinical Research Coordinator II

Location: Edgewater, FL; 100% ONSITE

Employment Type: Direct Hire

Candidate MUST be local to the area and have U.S. based experience

We’re partnering with a leading clinical research network to hire a Clinical Research Coordinator II . This is a direct hire opportunity for an experienced professional to take on a leadership role in the management and execution of clinical trials from start-up through closeout.

Position Overview:

The CRC II will serve as both a hands-on coordinator, ensuring trials are conducted in compliance with protocol guidelines, regulatory standards (GCP/ICH), and internal procedures.

Key Responsibilities:

• Coordinate all phases of the trial process including site activation, patient recruitment, visit scheduling, regulatory document management, data entry, safety reporting, and close-out activities.
• Maintain high standards for documentation and data integrity throughout the study lifecycle.
• Ensure all clinical trial activities align with applicable guidelines (GCP, ICH) and internal standards.
• Review and implement study amendments and protocol updates.
• Create risk mitigation and quality control strategies to enhance performance and compliance.
• Participate in subject screening and enrollment, including pre-screening and in-person assessments.
• Support the preparation and submission of regulatory documentation to IRBs and sponsors.
• Perform limited clinical procedures (as applicable and within scope), such as phlebotomy, ECGs, or sample processing.
• Ensure confidentiality and HIPAA compliance in handling patient and sponsor data.
• Actively contribute to patient safety monitoring and ensure accurate reporting of AEs/SAEs.
• Promote a respectful, inclusive environment and cultural sensitivity in all patient and team interactions.

Required Qualifications:

Candidates must meet one of the following minimum experience requirements:

• Bachelor’s degree and 2+ years of experience as a Clinical Research Coordinator
• Associate’s degree and 4+ years of experience in clinical research
• High School Diploma or technical degree and 6+ years of relevant experience

This is a great opportunity to join a reputable research site committed to clinical excellence and innovation. If you're passionate about improving patient outcomes and leading high-impact studies, we’d love to hear from you.

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