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Clinical Research Associate Ii

2+ years
Not Disclosed
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

Job Title: Sponsor Dedicated Clinical Research Associate (CRA)
Location: Bucharest, Romania (with some remote work flexibility)
Company: ICON Romania (part of ICON plc)

About the Role:

ICON Romania is seeking experienced Clinical Research Associates (CRAs) to join their FSP (Functional Service Provider) team in a sponsor-dedicated role. This position will involve working with a global biopharmaceutical company specializing in oncology, vaccines, infectious diseases, neuroscience, and cardiovascular fields. You will be working remotely with occasional visits to the sponsor's offices in Bucharest, usually one day per week.

Key Responsibilities:

  • Site Management:
    • Develop strong relationships with study sites and ensure continuity throughout all phases of the trial.
    • Perform site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local regulations, and study protocols.
    • Conduct site visits including initiation, monitoring, and close-out visits, ensuring accurate and timely reporting.
  • Study Documentation:
    • Collect, review, and maintain regulatory documentation for study start-up, maintenance, and close-out.
    • Ensure that the necessary documentation is available and up-to-date in the CTMS, eTMF, and other systems.
  • Communication and Collaboration:
    • Communicate with investigators and site staff about protocol issues, recruitment, retention, compliance, and site audits/inspections.
    • Work with cross-functional teams including finance, regulatory affairs, pharmacovigilance, legal, and external vendors.
  • Issue Resolution:
    • Identify, assess, and resolve any site performance, quality, or compliance issues.
    • Support and lead audit/inspection activities as necessary.
    • Mentor and act as a process Subject Matter Expert (SME) within the CRA team.

Requirements:

  • Education:
    • A B.A./B.S. in a science or biology-related field is preferred.
  • Experience:
    • At least 2 years of direct site monitoring experience in bio/pharma or CRO settings.
    • Experience in monitoring oncology trials is an advantage.
    • Proficiency in Good Documentation Practices.
    • Strong skills in site management, including performance management and patient recruitment.
  • Skills:
    • Good IT skills, with the ability to understand and analyze data/metrics.
    • Strong problem-solving abilities and a solution-oriented approach.
    • Ability to perform root cause analysis and implement corrective actions.

What ICON Offers:

  • Competitive Salary and benefits package.
  • Annual Leave Entitlements and a variety of health insurance options.
  • Retirement Planning offerings and global access to an Employee Assistance Program.
  • Life assurance, flexible country-specific benefits, and additional perks like childcare vouchers, gym memberships, and more.

Diversity and Inclusion: ICON values diversity and inclusion, ensuring a workplace free from discrimination and harassment. The company encourages candidates from all backgrounds to apply and offers reasonable accommodations during the application process for those with medical conditions or disabilities.

For more details about benefits and to apply, you can visit ICON’s careers page.