Jobs · Analyst · Massachusetts

Clinical Research Coordinator III

UMass Chan Medical School · Shrewsbury, MA · 3 wk ago
AnalystFull-time
Position Summary Under the general direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator III 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. Essential Functions Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAAAssist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocolsIdentify, 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 data. Provide data/support to study Investigators, sponsors and/or external monitors/auditorsDirect the activities of research support staff. Assist with the training of staffDevelop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processesAssist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframeConduct preliminary quality assurance reviews of study dataPresent study status reports related to assigned research projectsTrack and maintain study related information in the data management system within the required timeframeProvide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIsResponsible 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 practicesPerform other duties as required. Required Qualifications Bachelors degree in a scientific or health related field, or equivalent experience3-5 years of related experienceAbility to travel off site locations The University of Massachusetts Chan Medical School welcomes all qualified applicants and complies with all state and federal anti-discrimination laws.

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