Clinical Research Associate

vor 15 Stunden

Berlin, Berlin, Deutschland Parexel Vollzeit
{"title": "Clinical Site Monitor/CRA II", "description": "

Transforming Patients' Lives through Innovation

Parexel FSP is seeking a dedicated Clinical Site Monitor (CRA) I or II to join our team.

As a single sponsor dedicated to a worldwide biopharmaceutical company, we're committed to pushing the boundaries of medical innovation. Our daily efforts contribute to a healthier global community, and we're looking for like-minded individuals to join us.

Key Responsibilities:

The Site Monitor will be responsible for ensuring data integrity and quality, as well as compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for most activities to supplement on-site visit requirements.

The Site Monitor will collaborate with the Site Manager to ensure that the site follows the protocol and is inspection-ready. They will also coordinate with institutions and investigators at the local level.

Requirements:

  • A minimum of 1 year's experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite).
  • Experience in managing complex protocols in Oncology or other therapeutic areas (TAs) 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).

We Offer:

Exceptional financial rewards, training, and development opportunities. A healthy work-life balance and a commitment to your welfare, just as highly as that of our patients.

", "lang_code": "en-US"}

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