Phase I Research Coordinator — First-in-Human Trials

Green Life Science; Miami (FL); On-site; USD 65,000 - 105,000; Full time

Job summary

Green Life Science in Miami is seeking a hands-on clinical research professional to drive Phase I studies from start-up to close-out. You will screen, enroll, dose and monitor participants while supporting SAD/MAD, dose-escalation and FIH studies.

You will coordinate vital signs, ECGs, labs, PK/PD sampling and safety assessments, and ensure high-quality source documentation and EDC/eCRF data. Collaboration with investigators, sponsors and CROs is essential.

Qualifications

• 2+ years' clinical research experience.
• Direct Phase I experience is essential.
• Experience in a Phase I unit, early-phase site or SMO.
• Strong understanding of ICH-GCP and FDA requirements.
• Experience with participant screening, dosing and safety assessments.
• Excellent organisation, attention to detail and communication skills.

Responsibilities

• Coordinate Phase I studies from start-up through close-out.
• Manage participant screening, enrolment, dosing and follow-up.
• Support SAD/MAD, dose-escalation and FIH studies.
• Coordinate vital signs, ECGs, labs, PK/PD sampling and safety assessments.
• Monitor and document AEs, SAEs and protocol deviations.
• Maintain accurate source documentation and EDC/eCRF data.
• Work closely with Investigators, Sponsors, CROs and clinical teams.
• Support monitoring visits, audits and inspections.

Skills

Phase I experience

ICH-GCP & FDA knowledge

Documentation & data management

Communication skills

Study coordination

Job description

Green Life Science in Miami is seeking a hands-on clinical research professional to drive Phase I studies from start-up to close-out. You will screen, enroll, dose and monitor participants while supporting SAD/MAD, dose-escalation and FIH studies.

You will coordinate vital signs, ECGs, labs, PK/PD sampling and safety assessments, and ensure high-quality source documentation and EDC/eCRF data. Collaboration with investigators, sponsors and CROs is essential.