Clinical Research Coordinator
Winaxis LLC · Lewes, DE · 3 mo ago
On-siteInformation TechnologyFull-time
Key Responsibilities
- Monitor and manage clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory guidelines
- Conduct site initiation, monitoring, and close-out visits
- Verify accuracy and completeness of clinical data (source data verification)
- Ensure proper documentation and maintenance of trial master files (TMF)
- Collaborate with investigators, site staff, and cross-functional teams
- Identify, report, and follow up on adverse events and protocol deviations
- Train site personnel on study protocols and procedures
- Prepare monitoring reports and maintain study records
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
- Prior experience in clinical research or clinical trials preferred
- Strong understanding of GCP, ICH guidelines, and regulatory requirements
- Excellent organizational, analytical, and communication skills
- Able to travel to clinical trial sites (if required)
Skills & Competencies
- Attention to detail and problem-solving ability
- Time management and multitasking skills
- Strong interpersonal and teamwork abilities
- Proficiency in clinical trial management systems (CTMS) and MS Office
- Ethical mindset with a commitment to patient safety
Work Environment
- Combination of office-based and on-site monitoring work
- May require travel depending on study requirements
- Fast-paced, deadline-driven environment
Career Growth Opportunities
- Senior Clinical Research Associate
- Clinical Trial Manager / Project Manager
- Regulatory Affairs Specialist
- Clinical Operations Lead