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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