Clinical Research Coordinator I - Emergency Medicine

Job Description Summary Manages elements of a clinical study to meet all protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Responsibilities include start‑up, launch, day‑to‑day study management, and study closure activities. Essential Functions Recruits, consents, and enrolls subjects in accordance with ICH/GCP regulations, IRB, and relevant federal and state regulations. Assesses inclusion and exclusion criteria and alerts investigators to safety concerns, protocol deviations, or premature study termination requests. Collects, manages, and maintains accurate research data, including laboratory analytical procedures. Prepares and processes human specimens (blood, urine, etc.) for research studies; performs CLIA waived laboratory assessments, as required. Completes screening sheets and recruitment logs. Creates source documents that facilitate systematic data collection and aid in protocol execution and management. Collaborates, coordinates, and schedules subject visits with hospital services, the PI, and sub‑investigators. Adheres to departmental quality control guidelines. Completes Case Report Forms (CRFs) as instructed by the sponsor and ensures CRFs are completed before monitoring visits. Maintains the regulatory binder and associated documents. Education Requirements Associate’s Degree, or equivalent certification or experience, required. Bachelor’s Degree preferred. Certifications CNA, PCA, LPN, MA, or equivalent education or experience, required. Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire, required. Skills Understanding of medical terminology and clinical research preferred. Working knowledge of PCs and word processing and data management software. Demonstrated analytical skills with accuracy and attention to detail. Excellent verbal and written communication skills. Goal‑oriented and self‑directive. Strong organizational and interpersonal skills. Ability to actively participate as a team player. Experience Previous experience in clinical research or health care related field preferred. Physical Requirements Occasionally: cold temperatures, fumes/gases/vapors, loud noises, reaching above shoulder, squatting/kneeling. Frequently: bending/twisting, biohazard waste, blood and bodily fluids, chemicals/medications, communicable diseases and/or pathogens, lifting and carrying (0–10 lbs, 11–20 lbs, 21–40 lbs), machinery, patient equipment, pushing/pulling (0–25 lbs, 26–40 lbs, 41–60 lbs, 61–100 lbs), sitting, standing, walking. Continuously: audible speech, computer skills, decision making, depth perception, neck flexion/extension, hand use (grasping, gripping, turning), hearing acuity, data interpretation, peripheral vision, problem solving, repetitive hand/arm use, vision (far/near). EEO Statement EOE M/F/Disability/Vet #J-18808-Ljbffr Nationwide Children's Hospital