Clinical Research Associate Ii

2+ years

Not Disclosed

Romania

10 Dec. 24, 2024

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

Join ICON as a Sponsor Dedicated Clinical Research Associate (CRA)

ICON is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. ICON Romania is recruiting experienced Clinical Research Associates (CRAs) to join our FSP team in a sponsor dedicated role. This position primarily involves working remotely with occasional visits to the sponsor’s office in Bucharest (usually once per week). You'll be part of a global biopharmaceutical company specializing in Oncology, Vaccines, Infectious Diseases, Neuroscience, and Cardiovascular research.

What You Will Be Doing:

Site Relationship Management: Develop and maintain strong relationships with study sites, ensuring continuity throughout all trial phases.
Clinical Monitoring: Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws, and regulatory requirements.
Site Visits & Documentation: Conduct initiation, monitoring, and close-out visits, and maintain accurate visit reports and non-visit contact reports.
Regulatory Oversight: Manage required regulatory documentation for study start-up, maintenance, and close-out.
Collaboration: Work with investigators, site staff, and various internal and external teams (country operations, regulatory affairs, pharmacovigilance, etc.) to address protocol conduct, recruitment, retention, and compliance issues.
Site Performance Management: Identify, assess, and resolve issues related to site performance, quality, or compliance.
Audit Support: Support and/or lead audit/inspection activities as needed.
Knowledge Sharing: Act as a Subject Matter Expert (SME), mentor, and share best practices with the CRA team.
Data Management: Ensure accurate information management in CTMS, eTMF, and other systems.

Requirements:

Education: B.A./B.S. with a strong emphasis in science and/or biology.
Experience: At least 2 years of direct site monitoring experience in a bio/pharma/CRO environment. Oncology trial experience is an advantage.
Skills:
- Strong knowledge of Good Documentation Practices.
- Proven ability to manage site performance and patient recruitment.
- Proficiency in IT and data analysis.
- Ability to handle complex issues and perform root cause analysis.
Problem-Solving: Solution-oriented with experience in implementing corrective and preventative actions.

What ICON Can Offer You:

ICON values the quality of its people and fosters a diverse, high-performance culture. Along with a competitive salary, ICON offers a range of benefits focused on well-being, work-life balance, and family support, including:

Annual Leave: Various entitlements depending on location.
Health Insurance: A range of options for you and your family.
Retirement Planning: Competitive offerings to help you save and plan for the future.
Employee Assistance: 24-hour access to a global network of professionals through TELUS Health.
Life Assurance: Coverage to ensure your peace of mind.
Additional Benefits: Flexible country-specific benefits, such as childcare vouchers, gym memberships, and travel subsidies.

Visit our careers website to learn more about ICON's benefits.

Diversity and Inclusion at ICON:

At ICON, we believe diversity, inclusion, and belonging are essential to our success. Our diverse workforce fosters innovation and enables us to better serve our people, patients, customers, and communities. We are committed to creating an inclusive environment and providing equal opportunities for all candidates. If you need accommodations for any part of the application process, please let us know through the form below.

Request Reasonable Accommodation

Interested in the Role?

We encourage you to apply even if you're unsure whether you meet all of the requirements. We believe you could be exactly what we're looking for, whether for this role or others within ICON.

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Clinical Research Associate Ii

Job Description

What You Will Be Doing:

Requirements:

What ICON Can Offer You:

Diversity and Inclusion at ICON:

Interested in the Role?

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