Clinical Research Associate Ii

2+ years

Not Disclosed

Romania

10 Feb. 11, 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

Here’s the rewritten job description with a unique slug:

Clinical Research Associate II – ICON Strategic Solutions (Romania)

Employer: ICON Strategic Solutions
Location: Romania (Homeworking with occasional office visits in Bucharest)
Salary: Competitive
Start Date: 21 Jan 2025
Closing Date: 20 Feb 2025

About the Role

Join the world’s largest and most comprehensive clinical research organization as a Clinical Research Associate II (CRA II) with ICON Romania. This is a sponsor-dedicated role, requiring occasional office presence in Bucharest (typically one day per week or less, depending on monitoring visits). You’ll work with a global biopharmaceutical company specializing in Oncology, Vaccines, Infectious Diseases, Neuroscience, and Cardiovascular research.

Key Responsibilities

Build and maintain strong site relationships throughout the trial phases.
Conduct clinical study site management and monitoring in compliance with ICH-GCP, Sponsor SOPs, Local Regulations, Protocol, and Monitoring Plans.
Contribute to site selection and validation activities.
Perform on-site and remote monitoring, including initiation, validation, monitoring, and close-out visits.
Ensure timely and accurate documentation of visit reports.
Oversee regulatory documentation for study start-up, maintenance, and close-out.
Communicate with Investigators and site staff on protocol adherence, recruitment, regulatory documentation, audits, and inspections.
Identify, assess, and resolve site performance, quality, and compliance issues.
Collaborate with internal teams and external stakeholders (e.g., vendors, regulatory authorities, IRB/IECs).
Maintain accurate records in CTMS, eTMF, and other systems.
Act as a Subject Matter Expert (SME), mentor, and process advisor for the CRA team.
Support and lead audit/inspection activities when necessary.
Conduct co-monitoring visits as required.

Qualifications & Experience

B.A./B.S. degree (preferably in Science or Biology).
Minimum 2 years of direct site monitoring experience within a bio/pharma/CRO environment.
Oncology trial experience is an advantage.
Strong understanding of Good Documentation Practices.
Proven ability to manage site performance and patient recruitment.
Proficiency in IT tools and data analysis.
Problem-solving mindset, with the ability to conduct root cause analysis and implement corrective actions.

Benefits of Working at ICON

At ICON, we prioritize employee well-being, career growth, and work-life balance. Our benefits package includes:

Competitive salary and annual leave entitlements.
Comprehensive health insurance options for employees and families.
Retirement planning support for long-term financial security.
Global Employee Assistance Program (TELUS Health)—24/7 access to professional support.
Life assurance and flexible benefits, such as childcare vouchers, gym discounts, travel subsidies, and health assessments.

To learn more about ICON’s benefits, visit: ICON Careers.

Diversity & Inclusion at ICON

ICON is committed to fostering diversity, inclusion, and belonging. We provide an inclusive and accessible workplace, ensuring equal employment opportunities for all applicants. If you require a reasonable accommodation due to a medical condition or disability, please reach out via our form: ICON Accommodations.

Apply Now

If you’re interested but unsure if you meet all the requirements, we encourage you to apply! You might be exactly what we’re looking for—whether for this role or another opportunity within ICON.

#Clinical-Research-Associate-II-Romania

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Clinical Research Associate Ii

Job Description

Clinical Research Associate II – ICON Strategic Solutions (Romania)

About the Role

Key Responsibilities

Qualifications & Experience

Benefits of Working at ICON

Diversity & Inclusion at ICON

Apply Now

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