Clinical Research Coordinator II - RI Behav Trials Off

Overview The Behavioral Trials Office (BTO) works 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. Our work spans a variety of pediatric departments and developmental stages. 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 CRCs 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, institutional IRB, federal and state regulations; ensures inclusion/exclusion criteria; answers protocol procedure questions; acts as patient/family advocate. Coordinates and schedules subject study visits with hospital services and investigators; manages protocol-required data; performs study procedures per certifications and regulations; collects, processes and ships human specimens. Identifies study implementation issues and works with the study team to implement solutions to ensure progress and success. Assists with recruitment plan and provides input into budget; manages screening, enrollment and participation logs; completes recruitment summary at study termination. Creates source documents to facilitate systematic data collection and protocol execution; conducts accurate data entry. Maintains study database in de-identified format; completes Case Report Forms and ensures completeness prior to monitor visits. Educates study personnel on responsibilities and documents training. Alerts investigator when subject safety compromised, protocol deviation occurs, or premature termination requested. Maintains regulatory binder and handles IRB issues after study initiation. Assists principal investigator in preparing scientific publications and grant proposals. Education Requirement Associate's degree or equivalent experience, required. BA/BS, preferred. Licensure Requirement Certifications CRA/CRC certification, preferred. Skills Understanding of medical terminology and clinical trials. Proficiency with PCs, word processing, data management software. Analytical skills with accuracy and attention to detail. Excellent verbal and written communication skills. Goal-oriented, self-directed, able to manage complex projects independently. Strong organizational and interpersonal skills. Team player ability. Experience Eighteen months in clinical research or health care field, required. Physical Requirements Occasionally: cold temperatures, driving, exposure to fumes/gases/vapors, loud noises, reaching, kneeling. Frequently: bending, twisting, biohazard waste handling, blood/bodily fluids, chemicals, communicable diseases, lifting 0-10 lbs up to 100 lbs, standing, walking. Continuously: speech, computer skills, decision making, depth perception, neck flexion, hand use, hearing acuity, data interpretation, vision. Additional Physical Requirements Performed But Not Listed Above Not specified. EEO Statement EOE M/F/Disability/Vet. #J-18808-Ljbffr Nationwide Children's Hospital