Clinical Research Coordinator

Full Cycle Clinical Research Coordinator – Pulmonary/Respiratory Trials

Location:

Ocala, FL. Relocation assistance available for candidates willing to relocate to Florida.

• Coordinate day‑to‑day operations of pulmonary clinical trials under the Principal Investigator.
• Screen, recruit, and enroll eligible patients with respiratory conditions per protocol inclusion/exclusion criteria.
• Obtain and document informed consent in compliance with IRB and regulatory requirements.
• Schedule and conduct study visits, including spirometry, oximetry, blood draws, ECGs, and other respiratory assessments.
• Collect, process, and ship laboratory specimens per sponsor requirements.
• Ensure accurate and timely data entry in case report forms (CRFs) and electronic data capture (EDC) systems.
• Monitor and report adverse events (AEs) and serious adverse events (SAEs) per regulatory timelines.
• Maintain essential regulatory documents (e.g., 1572s, CVs, protocol signatures) and ensure compliance with ICH‑GCP.
• Communicate with study sponsors, CROs, and monitors, and assist during site visits, audits, and inspections.
• Collaborate with respiratory therapists, pulmonologists, and other healthcare professionals to facilitate patient care and protocol adherence.
• Maintain a working knowledge of current protocols and actively participate in study meetings and trainings.

• Bachelor’s degree in a health or science‑related field OR equivalent clinical experience.
• 1–3 years of experience coordinating clinical trials, preferably in a pulmonary or respiratory medicine setting.
• Knowledge of GCP, FDA regulations, and clinical trial processes.
• Strong organizational, time‑management, and multitasking skills.
• Excellent interpersonal and communication skills with patients and study teams.
• Proficiency with EDC systems and Microsoft Office Suite.

• Registered Respiratory Therapist (RRT) training/certification.
• Experience with pulmonary function tests (PFTs), FeNO, or bronchial provocation testing.
• Certification through ACRP (CCRC) or SoCRA (CCRP).
• Familiarity with pulmonary‑specific assessments (e.g., 6‑minute walk test, CT imaging coordination, sputum induction).

• Be part of cutting‑edge research improving treatments for chronic and rare pulmonary diseases.
• Collaborate with a dynamic, supportive team of clinical and research professionals.
• Opportunity for career development and growth in leading pulmonology research center.