Cra I

1+ years

Not Disclosed

Poland

10 April 18, 2025

Job Description

Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate I
Employer: ICON Strategic Solutions
Location: Poland, Homeworking
Salary: Competitive
Start Date: Apr 16, 2025
Closing Date: May 16, 2025

Job Details
ICON Strategic Solutions is seeking a Clinical Research Associate I (CRA I) to join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

What you will be doing

Act as the primary site contact and manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites.
Develop and maintain strong site relationships to ensure continuity throughout the trial.
Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, protocol, Site Monitoring Plan, and other associated documents.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready status.
Participate and provide input in site selection and validation activities.
Perform remote and on-site monitoring and oversight activities to ensure data integrity and subject safety.
Conduct site visits, including validation, initiation, monitoring, and close-out visits, and document visit and non-visit contact reports in a timely manner.
Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits, and overall site performance.
Work internally with various functional areas, including country operations, regulatory affairs, finance, and pharmacovigilance, as well as externally with vendors, IRBs/IECs, and Regulatory Authorities in support of assigned sites.
Manage and maintain information and documentation in CTMS, eTMF, and other systems according to established timelines.
Support or lead audit/inspection activities as needed.
Perform co-monitoring visits when appropriate.

Requirements

B.A./B.S. in a relevant field, with a strong emphasis on science and/or biology.
Minimum 1 year of direct monitoring experience.
Fluency in local languages and English (both verbal and written).
Excellent understanding of clinical research, clinical trial phases, GCP/ICH guidelines, and country-specific clinical research laws and guidelines.
Strong communication skills, including the ability to present technical information effectively.
Demonstrated ability to mentor/lead within a clinical research environment.
Hands-on knowledge of Good Documentation Practices.
Proven skills in site management, including managing site performance and patient recruitment independently.
Strong IT skills (MS Office, clinical IT applications on various devices).
Ability to analyze and interpret data/metrics and act accordingly.
Experience with conducting site motivational visits to boost site enrollment.
Solution-oriented and able to manage complex issues effectively.
Experience in performing root cause analysis and implementing corrective actions.

What ICON can offer you
ICON offers a competitive salary and additional benefits, including:

Various annual leave entitlements.
Health insurance options tailored to you and your family’s needs.
Competitive retirement planning options.
Global Employee Assistance Programme, offering 24-hour access to a network of over 80,000 professionals.
Life assurance and flexible benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, and more.

Visit our careers website to learn more about the benefits of working at ICON: https://careers.iconplc.com/benefits

Inclusion & Belonging
At ICON, we are dedicated to creating an inclusive and accessible environment. We are 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 veteran status. If you need accommodations during the application process, please let us know via the form below:
https://careers.iconplc.com/reasonable-accommodations

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Cra I

Job Description

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