Clinical Research Coordinator II - RI Biobehavioral Health

Overview The Behavioral Trials Office in the Center for Biobehavioral Health seeks a full‑time Clinical Research Coordinator to work with investigators and research teams to support our mission of providing efficient coordination of diverse behaviorally‑focused clinical research, including behavioral intervention trials and observational research. Example projects include: multi‑site implementation of a web‑based decision tool for adolescent males with cancer, how pre‑ and post‑natal exposure to air pollutants and early life stress impact reading and math learning difficulties in children ages 6–10, testing of a chatbot‑based app to connect families with unmet social needs to community resources, and an intervention to support Medicaid‑enrolled families with obesity improve cardiovascular health. Job Description Summary Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start‑up activities, launch activities, day‑to‑day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities. Essential Functions Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices. Recruits, consents and enrolls subjects according to ICH/GCP regulations and protects subjects’ rights through institutional IRB, federal and state regulations; ensures the subject meets inclusion/exclusion criteria; answers protocol‑related questions; acts as a patient/family advocate. Coordinates and schedules subject study visits with other hospital services and the PI/sub‑I; manages protocol‑required data; performs study procedures according to recognized skill level and certifications and within local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies. Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success. Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination. Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; conducts accurate and timely subject data collection. Assists with study database development to maintain study data in de‑identified format, according to recognized skill level; completes Case Report Forms (CRFs) and ensures CRFs are completed prior to monitor visits. Educates other study personnel with regards to study‑specific responsibilities and keeps written documentation of this training. Alerts the investigator when the subject’s safety is in jeopardy, when there is a protocol deviation, or when the subject requests premature study termination. Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder. Assists the principal investigator in the preparation of scientific publications and grant proposals. Education Requirements Associate’s degree or equivalent work‑related experience, required. BA/BS, preferred. Licensure Requirement Not specified. Certifications CRA/CRC certification, preferred. Skills Understanding of medical terminology and clinical trials, 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, ability to manage complex projects independently. Strong organizational and interpersonal skills.Ability to actively participate as a team player. Experience Eighteen months experience in clinical research or health care field, required. Physical Requirements OCCASIONALLY: cold temperatures, driving motor vehicles (work required), additional testing may be required, 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 lb, 11–20 lb, 21–40 lb, machinery, patient equipment, pushing/pulling 0–25 lb, 26–40 lb, 41–60 lb, 61–100 lb, 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. Additional Physical Requirements Not specified. EOE M/F/Disability/Vet. #J-18808-Ljbffr Nationwide Children's Hospital