Adverse Event Monitoring:

Track, document, and report adverse events and protocol deviations in accordance with regulatory requirements

Collaboration & Stakeholder Communication :

Coordinate with Principal Investigators, sponsors, monitors, and regulatory bodies to support study progress and resolve inquiries

Data Collection & Management:

Accurately collect, document, and enter study data into electronic systems, ensuring completeness and integrity

Patient Recruitment & Screening:

Identify, screen, and enroll eligible participants, including obtaining informed consent and reviewing medical records

Regulatory Compliance :

Maintain compliance with FDA, GCP, IRB, and HIPAA guidelines, ensuring all study activities meet required standards

Site Preparation & Documentation:

Maintain regulatory binders, case report forms, and essential study documents in audit-ready condition

Specimen Handling :

Collect, process, store, and ship biological samples in accordance with study protocols when applicable

Study Coordination :

Manage daily clinical trial operations, including scheduling subject visits, coordinating procedures, and ensuring protocol adherence

Subject Visit Management:

Coordinate participant visits, follow-ups, and study-related procedures to ensure a smooth and compliant experience Other Duties as

Assigned:

Support additional clinical research activities and operational needs as required What You'll Bring Bachelor's degree or higher required 1+ year of clinical research experience required 1+ year of phlebotomy experience preferred Experience working directly with patients in a clinical setting Strong understanding of medical terminology Excellent organizational skills and attention to detail Ability to work independently with minimal supervision Strong critical thinking and problem-solving abilities Professionalism and ability to maintain composure in all situations Strong interpersonal and communication skills with a positive, team-oriented approach Spanish language proficiency required What We Offer Comprehensive Medical Plans Dental Insurance Vision Insurance Employer-paid Life Insurance Employee Assistance Program (EAP) Paid Vacation Time Paid Sick Time Paid Federal Holidays Referral Program Opportunities for growth and development Equal Opportunity Employer We are an equal opportunity employer and comply with all applicable federal, state of Florida, and local employment laws. 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Clinical Research Coordinator