Medix™
Looking for candidates to relocate to FL. Relocation assistance available
Job Title: Full Cycle Clinical Research Coordinator – pulmonary/respiratory trials
Location: Ocala, FL
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator (CRC) to join our team and support our portfolio of Pulmonology clinical trials, including but not limited to studies involving asthma, COPD, interstitial lung disease, pulmonary hypertension, and cystic fibrosis. The CRC will play a critical role in managing day-to-day trial activities in compliance with Good Clinical Practice (GCP), regulatory requirements, and institutional guidelines.
Key Responsibilities
Coordinate and oversee the daily operations of clinical trials in Pulmonology under the supervision of the Principal Investigator (PI).
Screen, recruit, and enroll eligible patients with respiratory conditions in accordance with 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 protocol and 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 Required 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 Pulmonology 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).
Why Join Us
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 a leading Pulmonology research center.
#J-18808-Ljbffr
Job Title: Full Cycle Clinical Research Coordinator – pulmonary/respiratory trials
Location: Ocala, FL
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator (CRC) to join our team and support our portfolio of Pulmonology clinical trials, including but not limited to studies involving asthma, COPD, interstitial lung disease, pulmonary hypertension, and cystic fibrosis. The CRC will play a critical role in managing day-to-day trial activities in compliance with Good Clinical Practice (GCP), regulatory requirements, and institutional guidelines.
Key Responsibilities
Coordinate and oversee the daily operations of clinical trials in Pulmonology under the supervision of the Principal Investigator (PI).
Screen, recruit, and enroll eligible patients with respiratory conditions in accordance with 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 protocol and 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 Required 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 Pulmonology 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).
Why Join Us
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 a leading Pulmonology research center.
#J-18808-Ljbffr