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Clinical Research Associate I, Israel (Tinley Park,IL)

Company: Covance
Location: Tinley Park
Posted on: July 4, 2018

Job Description:

Clinical Research Associate I, Israel (Tinley Park,IL) Job Overview Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assignedResponsible for aspects of registry management as prescribed in the project plansGeneral On-Site Monitoring Responsibilities:Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure the resources of the Sponsor and Covance are spent wisely by performing theguidelines, including managing travel expenses in an economical fashion according to Covance travel policyrequired monitoring tasks in an efficient manner, according to SOPs and establishedTravel, including air travel, may be required and is an essential function of the job.Prepare accurate and timely trip reportsPerform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by managementAssist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site managementProvide coverage for clinical contact telephone lines, as requiredUpdate, track and maintain study-specific trial management tools/systemsGenerate and track drug shipments and supplies, as neededTrack and follow-up on serious adverse events as assignedImplement study-specific communication plan as assignedAttend investigators meetings, project team meetings and teleconferences, as neededAssist Senior CRA in managing investigator site budgetsPerform other duties as assigned by management Education / Qualifications University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)a minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.) Experience Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCPAbility to work within a project teamGood planning, organization and problem solving abilitiesGood communication skills, oral and writtenGood computer skillsWorks efficiently and effectively in a matrix environmentFluent in local office language and in English, both written and verbal

Keywords: Covance, Tinley Park, Clinical Research Associate I, Israel (Tinley Park,IL), Healthcare, Tinley Park, Illinois

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