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Clinical Nurse Reviewer I

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ICON plc

12d ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Chennai
  • Quick Apply

AI generated summary

  • You must be a Registered Nurse with 2+ years in clinical or drug development, possess critical thinking skills, have clinical research experience, and be detail-oriented.
  • You will collect, QC, and prepare adjudication packages, ensure compliance with regulations, respond to queries, generate reports, and manage case-related information for clinical trials.

Requirements

  • Registered Nurse is required along with two or more years of relevant work experience in drug development or clinical industry.
  • Excellent critical thinking skills
  • Should have clinical research experience
  • Data Management experience is a plus
  • Experience working with FDA regulations and reporting requirements and experience working with the MedDRA dictionary is preferred.
  • Experience working with electronic data (eCRFs), Microsoft Office Applications and other electronic data capture and transfer methods is highly desirable.
  • Excellent verbal and written communication skills. Must be detailed oriented and possess excellent organizational skills.
  • Willingness to travel 10%.
  • Must have knowledge of and adherence to all applicable aspects of Good Clinical Practices, Federal Regulations, International standards and company SOPs is required.

Responsibilities

  • Ensures 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.

FAQs

What is the job title for this position?

The job title for this position is Clinical Nurse Reviewer I.

What qualifications are required for this role?

A Registered Nurse license is required along with two or more years of relevant work experience in drug development or clinical industry.

Is clinical research experience necessary for this position?

Yes, clinical research experience is necessary for this position.

What kind of skills are sought after for this job?

Excellent critical thinking, verbal and written communication skills, attention to detail, and organizational skills are sought after.

Is experience with FDA regulations required?

Experience working with FDA regulations and reporting requirements is preferred.

Will there be an opportunity to travel in this role?

Yes, there is a willingness to travel up to 10%.

What are the main responsibilities of the Clinical Nurse Reviewer I?

The responsibilities include managing the collection, processing, analysis, and follow-up of dossiers for adjudication, ensuring quality and completeness of packages for Clinical Endpoint Committees, and generating reports for tracking performance and quality among adjudicators.

Are there any specific software or systems that the candidate needs to be familiar with?

Experience working with electronic data capture methods (eCRFs), Microsoft Office Applications, and coding using the MedDRA dictionary is highly desirable.

What are the benefits offered by ICON?

ICON offers competitive salary packages, health-related benefits, retirement plans, life assurance, and a global employee assistance program, among other benefits.

Does ICON practice equal opportunity employment?

Yes, ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

What should I do if I need a reasonable accommodation during the application process?

If you need a reasonable accommodation due to a medical condition or disability, please let ICON know or submit a request through the appropriate channels.

ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.