Clinical Research Associate Ii

2+ years

Not Disclosed

Romania

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 II
Employer: ICON Strategic Solutions
Location: Romania, Homeworking
Salary: Competitive
Start Date: Apr 16, 2025
Closing Date: May 16, 2025

Job Details
ICON Romania is looking for experienced Clinical Research Associates (CRAs) to join their FSP team. This sponsor-dedicated role requires occasional work at the sponsor's office in Bucharest, typically one day per week, depending on monitoring visits. You will work as part of a global biopharmaceutical company specializing in Oncology, Vaccines, Infectious Diseases, Neuroscience, and Cardiovascular.

What you will be doing

Develop and maintain strong site relationships through all phases of the trial.
Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, protocol, and related documents.
Participate in site selection and validation activities.
Perform remote and on-site monitoring and oversight activities.
Conduct site visits, including validation, initiation, monitoring, and close-out visits. Document visit and non-visit contacts 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 site performance.
Identify, assess, and resolve site performance, quality, or compliance issues.
Work in partnership with various functional areas, including country operations, regulatory affairs, legal, and external vendors.
Manage and maintain information and documentation in CTMS, eTMF, and other systems as per timelines.
Act as a process Subject Matter Expert (SME), mentor, and share best practices.
Support or lead audit/inspection activities as needed.
Perform co-monitoring visits when required.

Requirements

B.A./B.S. in a relevant field, with a strong emphasis on science and/or biology.
At least 2 years of direct site monitoring experience in the bio/pharma/CRO industry.
Experience in oncology trials is an advantage.
Hands-on knowledge of Good Documentation Practices.
Proven skills in site management, including site performance and patient recruitment.
Strong IT skills and the ability to analyze data/metrics effectively.
Solution-oriented approach to managing complex issues.
Ability to perform root cause analysis and implement corrective actions.

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

Various annual leave entitlements.
Health insurance options tailored to your and your family's needs.
Competitive retirement planning offerings.
Global Employee Assistance Programme, offering 24-hour access to specialized 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, inclusion and belonging are core to our culture. We are committed to providing a workplace free of discrimination and harassment. All qualified applicants will be considered regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need accommodations during the application process, please inform us via the form below:
https://careers.iconplc.com/reasonable-accommodations

If you're interested in the role but unsure whether you meet all the requirements, we encourage you to apply – there's a strong chance you're exactly what we’re looking for at ICON!

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Clinical Research Associate Ii

Job Description

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