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Clinical Site Monitor I/II

2 maanden geleden


Zwolle, Overijssel, Nederland Parexel Voltijd

About the Role:

Parexel FSP is seeking a highly skilled Clinical Site Monitor/CRA I or II to join our team. As a Clinical Site Monitor, you will play a critical role in ensuring the integrity and quality of clinical data, while ensuring compliance with ICH GCP and local regulations.

Key Responsibilities:

  • Conduct site monitoring activities in accordance with the Study Monitoring Plan (SMP) and ensure that sites are inspection-ready.
  • Collaborate with Site Managers to ensure that sites follow the protocol and are compliant with regulatory requirements.
  • Coordinate with institutions and investigators at the local level to ensure smooth site operations.

Requirements:

  • Minimum 1 year of experience as a clinical monitor with demonstrated experience in monitoring (virtual or onsite).
  • Experience in managing complex protocols in Oncology or other therapeutic areas where protocols are determined to be high risk.
  • Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.
  • Experience in utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence).

What We Offer:

Parexel FSP offers a competitive compensation package, opportunities for professional growth and development, and a collaborative work environment. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.