Senior CRA

ICON Clinical Research; Polska; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Life assurance

Retirement planning

Employee Assistance Programme (LifeWor

Childcare vouchers

Job summary

ICON Clinical Research is seeking a CRA II to support sponsor-dedicated monitoring with a focus on site visits, data quality, and patient safety. You will design and analyze trials, interpreting complex data, and contribute to innovative treatments.

The role requires at least 2 years of CRA experience, strong drug development knowledge, and proficiency with Veeva EDC, TMF, and CTMS. Travel up to 50% is expected, and benefits are provided.

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 execution processes.
• Experience delivering site monitoring and risk-based monitoring (on-site and remote).
• Experience navigating external vendor portals/reports and knowledge of Veeva EDC, TMF, CTMS.

Responsibilities

• Contributes to clinical trial monitoring activities and deliverables.
• Supports study execution teams with Site Monitoring and Site Management activities.
• Conducts site visits on-site and remotely to assess site suitability and study conduct.
• Reviews site records for protocol compliance, data quality, and participant safety (source data verification/review, site file review, drug accountability).
• Prepares and sends confirmation/follow-up letters; documents site interactions.
• Completes initial and ongoing study training; delivers training to site personnel.
• Reviews dashboards to prepare for site interactions and assess site compliance; partners with RBQM Operations.
• Provides ongoing site support, liaises with sites, and escalates issues as needed to Clinical Operations.
• Conducts Monitoring Oversight Visits to assess monitoring quality; supports additional sites/studies as requested.
• Maintains high quality and sponsor-procedures compliance across studies.

Skills

Site monitoring

CRA experience

Drug development knowledge

RBQM monitoring

Veeva EDC / TMF / CTMS

Education

Bachelor's in health-related field

Tools

Veeva EDC

TMF

CTMS

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.