Clinical Research Site Monitor I/II

vor 4 Wochen


Leipzig, Sachsen, Deutschland Pharmiweb Vollzeit
Position Overview

Pharmiweb is seeking a dedicated Clinical Site Monitor I or II to work remotely. The Site Monitor plays a crucial role in ensuring the integrity and quality of data collected at clinical sites, adhering to ICH GCP and local regulations.

Key Responsibilities
  • Conduct monitoring activities in accordance with the Study Monitoring Plan (SMP), primarily through virtual methods, while supplementing with on-site visits as necessary.
  • Collaborate closely with the Site Manager to guarantee that the site complies with the study protocol and remains prepared for inspections.
  • Coordinate effectively with local institutions and investigators to facilitate smooth operations.
Required Experience
  • A minimum of 1 year of experience as a Clinical Research Associate, demonstrating proficiency in monitoring, whether virtual or on-site.
  • Experience in site activation and management.
  • Knowledge of feasibility assessments and CRO oversight.
  • Familiarity with submissions processes (note: submission tasks are not part of this role).
  • Proficient 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) in a relevant field, or an equivalent combination of education, training, and experience.
What We Offer

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



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