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Syneos Health
Syneos Health
Sponzor vizuma H1BLogistikaSvetovanjeZdravstveno varstvo
Syneos Health je popolnoma integrirana organizacija za biofarmacevtske rešitve, ki strankam pomaga pri prenosu terapij od kliničnega razvoja do komercialne izvedbe. Njene ekipe združujejo klinične dejavnosti, medicinske zadeve, komercialne pristope, tehnologijo in tržne vpoglede, da bi se odzvale na spreminjajoče se potrebe zdravstvenega varstva ter podprle razvoj in uvedbo pomembnih zdravljenj po vsem svetu.
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Delovna mesta v podjetju

Senior Clinical Research Associate (CRA II) – Seoul

Monitor clinical trial sites for Syneos Health across South Korea, supporting GCP compliance, data quality, recruitment, and audit readiness. This hybrid clinical operations role combines site oversight with collaboration across study teams.

KRJužna KorejaHibridnoPolni delovni časSeniorZahtevani Jezik: angleščinaKlinične operacije
Google Cloud Platform

Opis

  • Conduct site qualification, initiation, interim monitoring, management, and close-out visits in person or remotely.
  • Maintain compliance with regulations, ICH-GCP/GPP standards, and study protocols.
  • Assess site and staff performance and recommend actions tailored to each site.
  • Escalate significant issues and create plans to address them.
  • Check informed consent practices, participant confidentiality and safety, and clinical data quality.
  • Review source records and confirm clinical data entered in case report forms.
  • Address queries remotely and on site, and advise site staff.
  • Assist with electronic data capture and check sites’ compliance with requirements.
  • Review investigational product inventory, reconciliation, storage, and security.
  • Examine Investigator Site Files and reconcile them against Trial Master Files.
  • Record monitoring work and follow up on observations and action items.
  • Contribute to participant recruitment, retention, and awareness efforts.
  • Coordinate site activities and communications to meet project goals, deliverables, and timelines.
  • Work with project site personnel to ensure assigned sites receive training and remain compliant.
  • Take part in investigator, sponsor, and clinical team meetings and training.
  • Help prepare for audits and complete follow-up actions.
  • Train and mentor junior clinical research associates.
  • When applicable, support late-phase real-world sites through chart abstraction and data collection.
  • Coordinate with sponsors, affiliates, medical science liaisons, local country teams, and regulatory groups.
  • Identify prospective sites, operational improvements, and activities outside the agreed scope.
  • Prepare country-specific informed consent forms and contribute to bid defense meetings.

Zahteve

  • A bachelor’s degree or RN qualification in a related field, or an equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice, ICH guidelines, and other applicable regulations.
  • Sound computer skills and willingness to adopt new technologies.
  • Strong communication, presentation, and interpersonal abilities.
  • Foundational critical thinking skills.
  • Ability to travel regularly, up to 75%.

Ugodnosti

  • Career development and advancement opportunities.
  • Supportive, engaged line management.
  • Training in technical and therapeutic areas.
  • Recognition from peers.
  • A total rewards program.
  • An inclusive workplace culture.
  • Reasonable accommodations when appropriate.

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