Kansas City, MO6 days ago
Responsible for all aspects of site management as prescribed in the project plansGeneral On-Site MonitoringEnsure 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 monitoring and data review for missing or implausible dataResponsible for all aspects of registry management as prescribed in the project plans; undertake feasibility work when requestedComplete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training of new employees, e.g., co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assignedPerform other duties as assigned by managementRequirements University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)1-3 years of Clinical Monitoring experienceOphthalmology experience as a CRAOpen to various hub locationsEnvironment & Characteristics The important thing for us is you are comfortable working in an environment that is:Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.