Job Description

We are seeking an organized, proactive, and adaptable part-time Clinical Research Coordinator with a strong emphasis on recruitment to support clinical trials from startup through closeout. In this multifaceted role, you will drive subject enrollment, conduct pre-screenings and chart reviews, manage participant scheduling, and support study coordination and electronic data capture activities in compliance with FDA, ICH, and GCP guidelines. This is a part-time opportunity.

Responsibilities

• Patient Recruitment & Outreach: Drive trial enrollment through targeted chart reviews, incoming media referral processing, pre-screening phone calls, medical record retrieval, and physician/community networking.
• Trial Coordination & Scheduling: Coordinate the schedule of study events for participants from screening through follow-up visits; send appointment reminders, manage calendars, and support patient-facing study activities.
• Data Management & Documentation: Abstract, collect, verify, and input clinical data into Electronic Data Capture systems; perform query resolution, SAE reconciliation, lab data verification, and ensure complete source documentation.
• Study Startup & Site Operations: Participate in site qualification visits, site initiation visits, and feasibility reviews; assist with essential regulatory documentation and IRB submissions as needed.
• Compliance & Sponsor Liaison: Serve as a key communication link between participants, Principal Investigators, study teams, and Sponsor/CRO representatives while maintaining strict adherence to protocol requirements and GCP standards.

Required Qualifications

• Proven clinical trial coordination experience with demonstrated hands-on experience in patient recruitment and enrollment workflows.
• Bilingual fluency in English and Spanish (required for participant outreach and phone screening).
• Demonstrated experience conducting chart reviews, phone screenings, and medical record retrieval.
• Working knowledge of FDA, ICH, and GCP guidelines, as well as IRB and essential document requirements.
• Hands-on experience with Electronic Data Capture systems, data entry, and query resolution.
• Excellent communication, organizational, and interpersonal skills.

Preferred Qualifications

• Prior experience managing end-to-end trial lifecycle activities from study startup through closeout.
• Familiarity with clinical trial financial milestones or payment-triggering documentation.
• Experience coordinating studies independently or alongside site research nurses.

Schedule & Logistics

• Role Type: Part-Time
• Hours: 24 hours per week (Day shifts between 8:00 AM – 5:00 PM, Monday – Friday). No evenings or weekends required. Choose 3 days to work on site!
• Schedule: Flexible scheduling across weekdays within standard clinic hours.
• Location: On-site in the Miami, FL area.

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