Clinical Research Coordinator II

Clinical Research Coordinator IIUnder the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator II is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for complex research protocols related to treatment, ancillary services, and prevention practices.ResponsibilitiesObtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAAIdentify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up callsEnsure accuracy and completion of all regulatory documentation, including local or central IRB and study dataConduct preliminary quality assurance reviews of study dataAssist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframePresent study status reports related to assigned research projectsContribute to data presentations and Institutional Review Board (IRB) processesTrack and maintain study related information in the data management system within the required timeframe Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIsContribute to the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)Responsible for monitoring the inventory of research related suppliesDocument and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding complianceComply with all safety and infection control standards appropriate to this positionAdhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices Perform other duties as required.QualificationsBachelor's degree in a scientific or health related field, or equivalent experience1-3 years of related experienceAbility to travel off site locations