Clinical Nurse Reviewer I

ICON is looking for a registered Nurse for the Clinical Nurse Reviewer role. The role involves managing activities relating to the collection, processing, analysis and follow-up of dossiers provided to Clinical Events Committees for marketed products and investigational compounds being studied in Endpoint Driven trials.

Job responsibilities

• Ensure timely collection of documents and components of Adjudication Packages for Clinical Endpoint Committees to allow quality and complete adjudication of potential clinical endpoints occurring in clinical trials. Collect, QC and ensure that the package content is medically complete and appropriate to allow physician adjudicators the ability to apply objective endpoint definitions to each case presented to them.
• Must have knowledge of and adherence to all applicable aspects of Good Clinical Practices, Federal Regulations, International standards and company SOPs is required.
• Will construct medically complete and logical adjudication dossiers for presentation to physician adjudicators. Also responses to queries from Physician adjudicators, Clinical Site Personnel, Company Personnel as it relates to collection of dossier components.
• Will be responsible for, in collaboration with project management, generating status and progress reports for committees and tracking performance and quality among adjudicators. They will also work with Project Management and Clinical Operations to generate all necessary committee documentation, preparing periodic reports and reviews of certain cases, identify potential sources of un-blinding, extract Endpoint/AE data from various source documents and spontaneous sources.
• Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries and ensure proper coding (MedDRA) into the Clinical Endpoint Committee database.

Role Requirements

• Registered nurse/physician with prior relevant clinical experience
• Highly developed problem solving skills
• Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
• Excellent computer skills (Microsoft Word, Excel, PowerPoint, Outlook).
• Experience working with electronic data capture and transfer methods
• Excellent knowledge of medical terminology
• Excellent communication skills
• Excellent organizational, time management and problem-solving skills
• Strong sense of responsibility and dedication
• Attentiveness to detail and accuracy; ability to maintain quality standards
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Proven ability to multi-task, manage competing priorities and timelines
• Willingness and aptitude to learn new skills