Job Title: Clinical Research Study Coordinator
Location: Chapel Hill, NC
Industry: Healthcare/Medical Clinical Research
Terms: Contract to Hire
Knowledge – Professional: This position requires full knowledge of clinical research principles as defined by Code of Federal Regulations, Good Clinical Practice (GCP) Parts 50, 54, 56, 312, 314 and ICH Guidelines; Health Insurance Portability and Accountability Act (HIPAA); Environment, Health and Safety (EHS) Blood borne Pathogens for Laboratory; Transportation of Dangerous Goods, 49CFR 172.700/IATA 1.5/Part 6, Chapter 1 of ICAO. This position also requires knowledge of information technology to complete assigned work and to analyze and report data and information. This knowledge enables the Study Coordinator to plan and conduct multiple complex trials and to engage knowledgably with sponsors, investigators, staff, and subjects to achieve research goals and ensure subject safety.
Job Title Job Summary:
Implementation of oncology... clinical research requires planning and teamwork in order to assure patient safety and research quality. The Study Coordinator coordinates multiple complex trials through the protocol life cycles of activation, implementation and closure. These trials are complex, requiring full knowledge of both GCP and full knowledge of individual research protocols; consequence of error could be significant physical harm to research subjects.
Study Coordinators independently plan, organize, and evaluate implementation of multiple oncology clinical research projects with knowledge of, and in compliance with, sponsor requirements. For each trial, acquire full knowledge of research protocol and related documents, plan and document methodologies for research subject and data management based on this knowledge.
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