Job Description

Location: Winter Park, FL – 100% On-site

Job Type: Full-Time, Permanent

Schedule: Monday–Friday, 8:00 AM – 5:00 PM (occasional off-hours for Phase I studies)

Urgency: Immediate hire – start by end of the month

Visa Sponsorship: Not available

Overview:

We are seeking an experienced Clinical Research Coordinator to join a fast-paced, multi-therapeutic research site. The ideal candidate has a strong background in clinical trial coordination, is detail-oriented, proactive, and thrives in a collaborative team environment.

Key Responsibilities:

• Coordinate start-up, conduct, and close-out phases of clinical trials (Phases I–IV)
• Conduct patient visits per protocol, including informed consent and study procedures
• Accurately document assessments, observations, and test results
• Ensure protocol, GCP, ICH, IRB, HIPAA, and regulatory compliance
• Maintain source documents and complete eCRFs and sponsor worksheets
• Report AEs and SAEs per protocol and within required timelines
• Communicate with study teams, investigators, and sponsors
• Track clinical trial supplies and ensure availability
• Attend Investigator Meetings, training sessions, and ongoing education
• Occasionally support community engagement efforts (no recruitment responsibilities)
• Maintain professionalism in all internal and external communications

Qualifications:

• 2–5 years of Clinical Research Coordinator experience (Phases I–IV)
• Experience with fast-paced trials and managing multiple patients/studies
• Familiarity with regulatory processes preferred
• Bachelor's degree preferred, but not required
• Clinical skills like phlebotomy and EKG are a plus
• Bilingual in Spanish is a plus, but not required
• Strong understanding of GCP, ICH, and FDA regulations
• Excellent written and verbal communication skills
• Proficient in Microsoft Office 365
• Ability to lift up to 35 lbs and travel locally as needed
• Must be a critical thinker, team-oriented, and adaptable

Workload Expectations:

• Studies per coordinator: 2–5 (based on complexity)
• Patients per day: 1–5
• Occasional support for Phase I studies requiring 24-hour coverage (team-shared)

Therapeutic Areas:

• Sleep, metabolic disorders, diabetes, obesity, cardiology, influenza, and more

What We Offer:

• Competitive salary based on experience
• Opportunity to work in a collaborative and growing clinical research environment
• Exposure to a wide range of therapeutic areas and fast-paced studies

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