Central Review Coordinator

ICON Clinical Research; United States; Remote; USD 65,000 - 85,000; Full time

Job summary

ICON Strategic Solutions is seeking a Central Review Coordinator in the United States to join the Central Review Services team. You will support centralized endpoint data evaluation, grading, and data management for a top sponsor, contributing to higher accuracy in endpoint measurement.

You will monitor deadlines, coordinate reviewer assignments, and liaise with directors and sponsors while ensuring documentation in eTMF and related systems.

Qualifications

• CRO experience within a clinical or CRO setting is required.
• Proven data management experience and comfort with clinical datasets.
• Strong written and verbal communication skills are essential.

Responsibilities

• Create and maintain Study Trackers.
• Monitor screening deadlines and ensure data entry timelines are met.
• Review study visits for readiness for CR review using status and query reports.
• Create, send and process assignments to reviewers, including query tracking.
• Compile files for patient profile creation and post on the Central Grading Portal.
• Prepare CRS meeting minutes and maintain action/decision logs.
• File documents in Central Grading Portal and eTMF.
• Coordinate with Directors, Therapeutic Experts and Sponsors.
• Monitor review progress and report issues and risks to the Lead Central Review Manager.
• Participate in database lock activities.
• Serve as CR Coordinator on one or more projects.

Skills

CRO experience

Data management

Communication skills

Time management

Attention to detail

MS Word/Excel

Education

BSc Life Science

Tools

Rave

Job description

Central Review Coordinator

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

This role as Central Review Coordinator offers the right candidate the opportunity to join the Central Review Services team; which is unique in the CRO industry. The team is solely focused on delivering independent, centralized endpoint data evaluation, grading, and data management for one of our Big Pharma FSPs. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.

Responsibilities include:

• Create and maintain Study Trackers.
• Monitor screening deadlines; follow up with sites on data entry and other vendor data entry and escape any visits that are not released for CR review or where queries are not being addressed within the timelines.
• Review and determine on study visits and sweeps are ready for review using the page status and query reports.
• Create, send and process assignments to reviewers, including query tracking.
• Download and compile files for the patient profile creation and post on the Central Grading Portal for the Data Programmer, CRS.
• Create internal CRS agenda and meeting minutes for distribution
• Action/Decision log updates/maintenance
• Filing of documents in Central Grading Portal and eTMF.
• Liaise with Directors, Therapeutic Expertise, internal team members and Sponsors.
• Performs proficient reviews of study datasets prior to client transfer, if applicable.
• Monitor review progress to meet timelines, identify issues, risks, possible solutions & report to Lead Central Review Manager.
• Participates in database lock activities.
• Serve as CR Coordinator on more or more projects.

You will have/be:

• BSc Life Science degree with solid experience working within a CRO and or the pharmaceutical industry
• A genuine interest in using your clinical experience to develop your career in clinical data
• Strong experience with at least one of the data management systems i.e. Rave
• Experience in most study tasks
• Comfortable working within a project team and have excellent written and verbal communication skills
• Experience in Microsoft Word and Excel
• Strong attention to detail
• Effective time management and prioritization skills

#LI-JF1 #LI-remote

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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here