The In-House CRA (IHCRA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or ICON's protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.What you will be doing:Performs a variety of routine essential document collection, review, and negotiation to ensure successful site activation and maintenance and close out tasks under general supervision.Performs recruitment of study sites, ensuring activities, documents, and all other clinical data are accurately tracked and documented for the project lifecycle. Escalates issues as needed.Completes submissions and notifications to regulatory authorities, ethics committee, and other bodies.May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).Performs and documents clinical data review and query creation, query resolution, offsite central monitoring contacts/visits, and site management communications as outlined in the study plans (and/or other processes).Sets up and maintains study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems according to project protocol, applicable SOPs, and project plans.You are:Bachelor's degree or its international equivalent in clinical, science, or health-related field.Previous experience in clinical research with ethics submissions.Clinical trials support or pharmaceutical industry experience preferred.Read, write, and speak advanced English; fluent in host country language required.Prior experience using computerized information systems.Experience with PC-Windows, word processing, and electronic spreadsheets preferred.Knowledge of ICH and local regulatory authority drug research and development regulations preferred.What ICON can offer you:Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.
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