Medix™
Full Cycle Clinical Research Coordinator – Pulmonary/Respiratory Trials
Location: Ocala, FL. Relocation assistance available for candidates willing to relocate to Florida.
Responsibilities
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. Qualifications
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. Preferred Qualifications
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). Benefits
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.
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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. Qualifications
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. Preferred Qualifications
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). Benefits
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.
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