Clinical Research Coordinator I - Emergency Medicine

Overview Manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to: start-up activities, launch activities, day-to-day management of a study and study closure activities. Essential Functions Recruit, consent, and enroll subjects according to ICH/GCP regulations and institutional IRB, federal and state regulations. Answer questions related to protocol procedures and act as patient/family advocate. Ensure subjects meet inclusion/exclusion criteria and report safety concerns, protocol deviations, or premature study termination requests. Collect and manage research data and subject information, maintaining accurate data collection of all study data including laboratory analytical procedures. Prepare and process human specimens, collecting blood, urine, and other samples as needed according to skill level and certifications. Perform CLIA waived laboratory assessments. Complete screening sheets and recruitment logs and create source documents to facilitate systematic data collection and protocol execution. Collaborate, coordinate, and schedule subject study visits with other hospital services and the PI/sub-I. Adhere to departmental quality control guidelines and complete Case Report Forms (CRFs) as instructed by the sponsor, ensuring CRFs are completed prior to monitoring visits. Maintain regulatory binder and documents. Education and Certification Associate's Degree or equivalent certification/experience required (Bachelor's Degree preferred). Required certifications: CNA, PCA, LPN, MA, or equivalent education/experience. Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire required. Skills and Experience 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. Previous experience in clinical research or health‑care related field (preferred). Physical Requirements Occasionally: cold temperatures, fumes/gases/vapors, loud noises, reaching above shoulder, squat/kneel; frequently: bend/twist, biohazard waste, blood and/or bodily fluids, chemicals/medications, communicable diseases and/or pathogens, lifting/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, flexing/extending of neck, hand use: grasping, gripping, turning, hearing acuity, interpreting data, peripheral vision, problem solving, repetitive hand/arm use, seeing – far/near. EEO Statement EOE M/F/Disability/Vet #J-18808-Ljbffr 10 Nationwide Children's Hospital