Cra II

IRE; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Competitive base salary

Health & wellbeing programs

Retirement and pension plans

Life assurance & disability

Employee assistance programs

Career development opportunities

Job summary

ICON is seeking a CRA II to support clinical trial monitoring and site management activities. You will conduct on-site and remote visits, assess site suitability, ensure data quality and participant safety, and collaborate with study teams to meet delivery timelines.

The role requires 2+ years as a CRA, strong understanding of drug development, and experience with Veeva EDC, TMF, and CTMS. Travel up to 50% is expected, with potential international assignments.

Qualifications

• Bachelor’s degree in a health-related field or international equivalent preferred.
• Site Monitor: Minimum of 2 years of CRA experience.
• Robust understanding of drug development and clinical trial processes.

Responsibilities

• Contribute to clinical trial monitoring activities and deliverables.
• Conduct site visits (on-site and remote) to assess site suitability and study conduct.
• Review site records for protocol compliance, data quality and participant safety.

Skills

Site monitoring

Remote monitoring

RBQM knowledge

Veeva EDC

TMF

CTMS

Education

Bachelor’s Degree in health-related field

Tools

Veeva EDC

TMF

CTMS

Job description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.