Site Coordination Specialist

6 dni temu

Warszawa, Mazovia, Polska ICON Pełny etat

Clinical Research Coordinator is a critical member of the investigative site team, responsible for ensuring the successful conduct of clinical research studies according to project-specific requirements and regulatory guidelines.

This role involves assisting in study-related activities at the site level, ensuring compliance with protocols, Standard Operational Procedures (SOPs), and international and local clinical trial regulations (ICH GCP Guidelines, CFR, GDPR, HIPAA, etc.).

The successful candidate will serve as a primary point of contact for Investigator Site Staff and Sponsor representatives, supporting organization and execution of monitoring visits and audits at the Investigator Site. They will also be responsible for entering patient-specific data into applicable clinical systems (eCRF, ASM, etc.) and assist in resolving data queries.

Responsibilities:

  • Primary point of contact for Investigator Site Staff and Sponsor representatives.
  • Support organization and execution of monitoring visits and audits at the Investigator Site.
  • Enter patient-specific data into applicable clinical systems (eCRF, ASM, etc.) and assist in resolving data queries.
  • Coordinate patient visits and communication.
  • Collaborate with external service providers, such as central laboratories and couriers.
  • Maintain accurate records of the Investigator Site File and patient documentation.
  • Participate in regular meetings and teleconferences.
  • Perform additional study-related tasks as required by the Investigator.
  • Report any site operation issues to the Line Manager.
  • Provide timely reports on completed activities.

Requirements:

  • Bachelor's degree in a relevant field, such as business administration or project management.
  • Experience in a similar role or environment, with a focus on oncology project support.
  • Strong analytical and problem-solving skills, with attention to detail.
  • Excellent communication and interpersonal skills, with a collaborative approach.
  • Proficiency in relevant software applications and tools.

What We Offer:

We provide a competitive salary and benefits package, opportunities for professional growth and development, and a diverse and inclusive workplace culture.

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