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    Clinical Research Associate Ii

    Icon
    2+ years
    Not Disclosed
    Romania
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.A./B.S 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 a polished and structured version of the Clinical Research Associate II job description for ICON Romania:

    Position: Clinical Research Associate II (Sponsor Dedicated)
    Company: ICON Romania
    Location: Hybrid (Occasional sponsor office work in Bucharest)

    About ICON Romania
    ICON Romania, a part of the world’s largest and most comprehensive clinical research organization, is powered by healthcare intelligence. We are seeking experienced Clinical Research Associates (CRAs) to join our Functional Service Provider (FSP) team. This is a sponsor-dedicated role with hybrid working arrangements, including minimal office presence in Bucharest (usually 1 day per week or less, depending on monitoring visit schedules).

    What You’ll Be Doing

    As a CRA II, your responsibilities include:

    • Building and maintaining strong site relationships throughout all phases of the trial.
    • Performing clinical study site management and monitoring activities in adherence to ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocols, Site Monitoring Plans, and associated documentation.
    • Participating in and contributing to site selection and validation activities.
    • Conducting remote and on-site monitoring and oversight visits, including:
      • Validation visits.
      • Initiation visits.
      • Monitoring visits.
      • Close-out visits.
    • Ensuring timely and comprehensive documentation of site visits and non-visit contact reports.
    • Collecting, reviewing, and monitoring required regulatory documentation for all study phases.
    • Communicating with Investigators and site staff regarding protocol conduct, recruitment, deviations, audits, and overall site performance.
    • Identifying and resolving site performance, quality, or compliance issues.
    • Collaborating with internal departments (operations, finance, regulatory affairs, pharmacovigilance, legal, etc.) and external stakeholders (vendors, IRBs/IECs, Regulatory Authorities) to support site activities.
    • Managing and maintaining documentation in CTMS, eTMF, and other relevant systems.
    • Sharing knowledge as a Subject Matter Expert (SME), mentor, or buddy, and leading process improvements when needed.
    • Supporting and/or leading audit and inspection activities.
    • Performing co-monitoring visits where applicable.

    Requirements

    To succeed in this role, you should have:

    • Education: Bachelor’s degree (B.A./B.S.) with an emphasis in science/biology or equivalent experience.
    • Experience: Minimum 2 years of direct site monitoring in a bio/pharma/CRO environment.
    • Skills:
      • Strong knowledge of Good Documentation Practices.
      • Proven expertise in site management, performance, and patient recruitment.
      • Proficiency with IT tools and data analysis.
      • Problem-solving, root cause analysis, and implementing corrective actions.
      • Strong interpersonal, communication, and organizational skills.

    What ICON Offers

    At ICON, we value and reward our people through competitive salaries and benefits that prioritize well-being and work-life balance. Examples include:

    • Generous annual leave policies.
    • Comprehensive health insurance tailored to you and your family.
    • Competitive retirement planning options for financial security.
    • Global Employee Assistance Program, providing 24/7 access to specialized professionals for you and your family.
    • Life assurance.
    • Flexible country-specific benefits, such as childcare vouchers, gym discounts, subsidized travel passes, and more.

    Diversity & Inclusion at ICON

    Diversity, inclusion, and belonging are core to ICON’s culture and values. We are committed to creating an inclusive environment where all employees feel valued and supported. ICON provides equal opportunities to all applicants, regardless of race, color, religion, sex, gender identity, sexual orientation, disability, or veteran status.

    Reasonable Accommodations
    If you require accommodations during the application process or in your role due to a medical condition or disability, please let us know through our dedicated accommodations form: Request Accommodations.

    Interested but Unsure?
    We encourage all candidates to apply, even if you don’t meet every requirement. You may be the perfect fit for this or another role at ICON!

    Apply Now

    #LI-DS1 #LI-Hybrid

    This version emphasizes clarity, structure, and engagement for potential candidates. Let me know if you need further adjustments!

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    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote - Africa | Castlebar | Thailand | Tulsa | Remote, USA | Lousiana | Remote - South America (Latin Americal) | Melbourne | Victoria | Ireland | Xzagreb | Zaragoza | Belgium | Bountiful | Lenexa | Remote - Europe | McFarland | Remote | Remote - Middle East | Hungary | Slovakia | Manipal | Springville | Hammond | Riga | Nairobi | Leinster | Minnesota | French | Faridabad | Texas | Bishop | Green Way | Medan | Blue Bell | Switzerland |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | King Abdullah Economic City | Jeddah | Khulais | Rabigh | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |