CRA II

ICON; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Country-specific benefits

Job summary

ICON Strategic Solutions is seeking a CRA II to design and analyse clinical trials, interpret complex data, and contribute to the development of innovative treatments. You will monitor sites, review data quality, and ensure safety across sponsor-dedicated studies.

The role involves on-site and remote monitoring with up to 50% travel, collaborating with study teams and vendors to maintain quality and compliance throughout trials.

Qualifications

• Bachelor’s degree in health-related life sciences or international equivalent preferred.
• Site Monitor: minimum 2 years of CRA experience.
• Solid understanding of drug development and clinical trial execution processes.
• Experience delivering site monitoring and risk-based monitoring, onsite and remote.
• Familiar with external vendor portals/reports and Veeva EDC, TMF, CTMS.

Responsibilities

• Support site monitoring and site management activities across studies.
• Conduct site visits on-site and remotely to assess suitability and conduct.
• Review source data and site records for protocol compliance and safety.
• Prepare and send monitoring letters; document interactions in visit reports.
• Review dashboards and RBQM findings; coordinate with RBQM operations.
• Provide ongoing site support and escalate issues as needed.
• Perform Monitoring Oversight Visits as required.

Skills

CRA experience

Drug development knowledge

Risk-based monitoring

Veeva EDC / TMF / CTMS

Education

Bachelor’s Degree in health-related, life science area

Tools

Veeva EDC

Job description

POL-CRA II-HB

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.

As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

• As assigned to support study execution teams, responsible for the implementation of Site Monitoring and Site Management activities
  • Conducts site visits on-site and remotely to confirm initial and ongoing site suitability and to assess study conduct. Includes pre-study, site initiation, interim monitoring, site close-out, and monitoring oversight visits.
  • Follows study-specific site monitoring plans to assess and support sites’ compliance with the protocol, data quality, and participant safety - via the review of site and subject records. This includes but is not limited to source data verification, source data review, investigator site file review, and drug accountability activities.
  • Develops and sends confirmation and follow-up letters to provide clear communications with sites and documents all site interactions in appropriate site monitoring visit report documentation per sponsor requirements in sponsor systems.
  • Completes initial and ongoing study training; delivers and documents relevant study training with site personnel.
  • Reviews systems and dashboards to prepare for site interactions and to assess site compliance with study requirements (e.g., EDC status as well as eCOA compliance). Partners with RBQM Operations to address centralized monitoring findings with sites, and support sites in RBQM processes.
  • Provides ongoing site support / management, liaising with sites to address questions, triage study needs, and resolve issues with and for sites. Escalates site issues as needed to Clinical Operations representatives (e.g., CSSM, CSM, RBM Lead).
  • Conducts Monitoring Oversight Visits to assess site monitoring quality and/or resolve issues in site data quality or site monitoring quality for additional sites/studies as requested.
• Maintains high quality, consistency, and compliance with sponsor procedures across studies
• Recommends monitoring process adjustments based on experience during and after the completion of study activities
• Acts as a change agent, subject matter expert, and point of contact for risk-proportionate site monitoring concepts with sponsor study teams
• Supports and participates in internal and external audits and inspections as requested

Your Profile

• Bachelor’s Degree in a health-related, life science area or international equivalent preferred
• Site Monitor: Minimum of 2 years of experience as CRA
• Robust understanding of the drug development and clinical trial execution processes
• Experience successfully delivering site monitoring and risk-based monitoring, including onsite and remote monitoring models
• Experience in navigating external vendor portals / reports, and knowledge of Veeva EDC, TMF, and CTMS

Travel Requirements

• Requires minimum 50% travel, including overnight and potentially international travel

#LI-DD1

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.

Visit our careers site to read more about the benefits ICON offers.

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