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Clinical Research Site Monitor I/II

vor 2 Monaten


Leipzig, Sachsen, Deutschland Pharmiweb Vollzeit
Position Overview

Pharmiweb is seeking a dedicated Clinical Site Monitor I or II to work remotely. The successful candidate will play a crucial role in ensuring the integrity and quality of clinical data while adhering to ICH GCP and local regulations at the site level.

Key Responsibilities
  • Conduct monitoring activities in accordance with the Study Monitoring Plan (SMP), primarily through virtual means, supplemented by necessary on-site visits.
  • Collaborate closely with the Site Manager to ensure compliance with the study protocol and maintain site readiness for inspections.
  • Coordinate effectively with local institutions and investigators to support study objectives.
Qualifications

To be considered for this role, candidates should possess:

  • A minimum of 1 year of experience as a Clinical Research Associate, with proven monitoring experience (both virtual and on-site).
  • Experience in site activation and management.
  • Knowledge of feasibility assessments and CRO oversight.
  • Familiarity with submission processes (note: this role does not involve direct submissions).
  • Proficiency in using systems such as Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence).
  • A Bachelor's degree or Registered Nurse (RN) qualification in a relevant field, or an equivalent combination of education, training, and experience.
What We Offer

We provide competitive financial rewards, comprehensive training, and opportunities for professional development. Expect to face engaging challenges while maintaining a healthy work/life balance. Your well-being is as important to us as that of our patients.

We look forward to your application.