Clinical Research Coordinator I - Department of Neurology

Independent study coordination including screening of potential research participants for protocol eligibility, -presenting non-medical trial concepts and details to the research participants, and participating in the -informed consent process. -Scheduling of research participants for research visits and procedures. -In collaboration with the physician and other medical personnel, documents thoroughly on Case Report -Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant -medication use, protocol compliance, response to study drug. -Maintains accurate source documents related to all research procedures. -Responsible for accurate and timely data collection, documentation, entry, and reporting including timely -response to sponsor queries. -Schedules and participates in monitoring and auditing activities. -Responsible for compiling and reporting on each study including information related to protocol activity, -accrual data, workload, and other research information; presents this information at regular research staff -meetings. -Notifies direct supervisor about concerns regarding data quality and study conduct. -Independently works with external study monitors and/or auditors.Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit -initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol -deviations, and Safety Letters in accordance with local and federal guidelines. -May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with -research participant billing and reconciliation. -May supervise Clinical Research Associates on data entry, data query, and resolution. -Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) -and local Institutional Review Board. -Maintains research practices using Good Clinical Practice (GCP) guidelines. -Maintains strict research participant confidentiality according to HIPAA regulations and applicable law. -Participates in required training and education programs. -
Education:High School Diploma/GED, requiredBachelor's -Degree, preferredLicense/Certification/Registration:ACRP/SoCRA (or equivalent) certification, -preferredExperience:One (1) year -clinical research related experience, -requiredOne (1) year -involvement in coordiantion of clinical research trials -Physical Demands: - -Lifting, standing, walking -
Working Title:Clinical Research Coordinator I - Department of Neurology
Department:Neurology
Business Entity:Academic / Research
Job Category:,Academic/Research,Academic/Research
Job Specialty:Research Studies/Clinical Trials
Position Type:Full-time
Shift Length:8 hour shift
Shift Type:Day

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