CRA II

ICON Strategic Solutions; Poland; Hybrid; PLN 140,000 - 210,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Global Employee Assistance Programme/L

Life assurance

Annual leave entitlements

Flexible benefits

Job summary

ICON plc is seeking a CRA II to design and analyse clinical trials, interpret complex data, and advance new therapies. You will perform site monitoring on-site and remote visits, support study teams, and ensure data quality and patient safety while working with RBQM processes and sponsor systems.

Travel up to 50% is expected. The role requires a health-related bachelor’s degree, 2+ years CRA experience, and strong knowledge of drug development, Veeva EDC, TMF, and CTMS.

Qualifications

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

Responsibilities

• Support study execution teams with Site Monitoring and Site Management activities.
• Conduct site visits on-site and remotely; confirm site suitability and study conduct.
• Review site/subject records for protocol adherence, data quality and safety.
• Prepare and send site monitoring visit reports and documentation in sponsor systems.
• Deliver and document study training for site personnel.
• Review dashboards and RBQM findings; address centralized monitoring with sites.
• Provide ongoing site support and escalation of issues to Clinical Operations.
• Conduct Monitoring Oversight Visits to assess monitoring quality.

Skills

Site monitoring

Remote monitoring

RBQM knowledge

Veeva EDC

CTMS

Risk-based monitoring

Education

Bachelor’s degree in health-related field

International degree equivalent

Tools

Veeva EDC

TMF

CTMS

Job description

POL-CRA II-HB

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

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.