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    Clinical Research Associate - Oncology

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    1+ years
    Not Disclosed
    Remote, USA
    10 Sept. 25, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Position: Clinical Research Associate (CRA)

    Company Overview: Join the world’s largest and most comprehensive clinical research organization, driven by healthcare intelligence. At ICON, we focus on delivering innovative solutions that ensure compliance with regulatory, ICH-GCP, and study protocol standards.

    Key Responsibilities:

    • Evaluate site performance and staff compliance, recommending site-specific actions while escalating significant issues to the project team.
    • Ensure the informed consent process is properly conducted and documented for each participant, while safeguarding patient confidentiality.
    • Conduct monitoring activities as outlined in the Clinical Monitoring/Study Monitoring Plan (CMP/SMP), utilizing both on-site and remote methods as permitted by local regulations.
    • Perform Source Document Review and Source Data Verification, ensuring accuracy and completeness of clinical data in case report forms (CRFs).
    • Manage reporting of protocol deviations and follow-up as necessary.
    • Resolve queries through effective communication with site staff, driving resolution within set timelines.
    • Oversee investigational product (IP) inventory, ensuring proper handling and compliance with protocols.
    • Document activities meticulously via monitoring reports, communication logs, and other required project documents as per SOPs.
    • Ensure site personnel are appropriately trained and delegated for their responsibilities.
    • Track observations and action items through data entry into tracking systems, maintaining ongoing communication about project scope, timelines, and deliverables.
    • Review data entry timelines, site logs, and compliance with training requirements for site personnel.
    • Collaborate with the primary Site Manager, attending investigator meetings and project staff meetings to ensure effective communication.
    • Prepare for audits and maintain readiness standards at the site level.

    Training and Education:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.

    Prior Experience:

    • Minimum of 12 months of experience as a clinical monitor, with at least 6 months of oncology monitoring experience.

    Technical Competencies:

    • Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
    • Proficiency in computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage travel requirements of up to 75%.
    • Experience with systems like Siebel CTMS, eTMF, and eISF (Florence) or proven ability to learn new systems quickly.

    Behavioral Competencies:

    • Ability to overcome barriers in implementing new processes and systems.
    • Strong relationship-building skills with site staff and stakeholders.
    • Effective verbal and written communication skills for engaging with internal and external parties.

    What ICON Offers You: At ICON, we recognize that our success is built on the quality of our people. We prioritize a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits designed to promote well-being and work-life balance:

    • Various annual leave entitlements
    • Comprehensive health insurance options for you and your family
    • Competitive retirement planning to support future savings
    • Global Employee Assistance Program offering 24/7 access to health professionals
    • Life assurance and flexible country-specific optional benefits

    Diversity and Inclusion: At ICON, diversity, inclusion, and belonging are central to our values. We are committed to creating an inclusive and accessible environment for all candidates. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need reasonable accommodations during the application process or to perform essential job functions, please let us know.

    Application Process: If you’re interested in this role but unsure about meeting all the requirements, we encourage you to apply. You may be exactly what we’re looking for.

    Note: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

    For more information about the benefits of working at ICON, please visit: ICON Careers Benefits.

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    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    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 |