Clinical Nurse Reviewer I
About the role
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The Clinical Reviewer 1 provides a supporting role to the Project Manager in the coordination and receipt of clinical trial endpoint supporting source documentation. The Clinical Reviewer 1 is primarily responsible for clinical content review of the endpoint source documentation for adjudication by Endpoint Adjudication Committee. |
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 20%) domestic and/or international.
- Assists the Project Manager in the development of project specific procedures, and workflows, as requested
- Communicates with the study team (ie sites, CRAs, Committee Members) as necessary regarding the endpoint source document requirements and collection process.
- Assists with project specific process/system training for study team (ie sites, CRAs, Committee Members), as directed by Project Manager.
- Attends internal and external project team meetings as needed.
- Provides input to the development and review of study documents (ie Site Manual, Procedure Manual, Adjudication Forms) as requested by Project Manager.
- Processes source documents as necessary.
- Provides clinical judgment during the review of source documents to determine if the information is sufficient for the reported clinical endpoint to be adjudicated.
- Redacts project specific clinical data from source documents as necessary.
- Issues and closes site queries for outstanding source documentation, per Procedure Manual.
- Follows project escalation plan regarding site follow up for outstanding source documentation
- Uses the electronic adjudication system, or other related systems for tracking, running reports, or viewing endpoint data.
- Supports the Project Manager in the collection of project metrics related to source document collection and clinical review.
- Assists the Project Manager to ensure timely collection of endpoint supporting source documentation in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
- Keeps Project Manager apprised of any potential/actual project issues and develop solutions for same
- Processes requests from Endpoint Adjudication Committee Members for additional information.
- Reviews documentation changes, or additional documentation received post adjudication for relevance and the need for re-adjudication.
- Assist in training/mentoring of new employees, ensuring that they are performing clinical review per established procedures with minimal rate of error.
- Identifies out of scope activities and process efficiency/improvement needs to management
- Assists in ensuring audit readiness.
- Perform other activities as identified and requested by management
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- • US/LATAM/CAN: a minimum 3 years of clinical experience.
- • EU/APAC: 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
- • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees’ location, the employee may be required to possess a valid Drivers license.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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