POSITION SUMMARY:Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator I 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 research protocols related to treatment, ancillary services, and prevention practices.
ESSENTIAL FUNCTIONS:Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAAIdentify, schedule and/or conduct participant study visits, interviews, and testsCoordinate participant remuneration/compensation per protocolMaintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditorsIdentify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding complianceDocument and collect data and/or samples for research related procedures performed during participant study visits.Ensure clinicians and/or PI accurately document their study activities according to protocolTrack and maintain study enrollment and completion of milestonesAssist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.Track and maintain study related information in the data management system within the required timeframeResponsible for monitoring the inventory of research related suppliesParticipate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processesProvide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIsPresent study status reports related to assigned research projectsParticipate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)Maintain strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.Comply with all safety and infection control standards appropriate to this positionAdhere with established policies, health and safety regulations and requirements, procedures, and department objectivesAdhere to Good Clinical Practice (GCP) guidelines and all human subject protection practicesMust practice discretion and adhere
REQUIRED QUALIFICATIONS:Bachelors degree in a scientific or health related field, or equivalent experience0-1 year of related experienceAbility to travel off site locationsSUPERVISION RECEIVED:Under the direction of the Principle Investigator or designeeSUPERVISION EXERCISED: NoneENVIRONMENTAL WORKING CONDITIONS:Usual office environment, laboratory, medical, surgical, and off campus study sites