ClinSol GmbH & Co. KG logo
ClinSol GmbH & Co. KG

Klinische Auftragsforschung und Medical Education

Clinical Monitor, Clinical Research Associate, CRA

Research AnalystResearch AnalystFull TimeRemoteMid LevelTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Germany

Posted

1 day ago

Salary

0

Seniority

Mid Level

Bachelor Degree1 yr expGermanEnglishGoogle Cloud Platform

Job Description

Clinical Monitor, Clinical Research Associate, CRA

ClinSol GmbH & Co. KG

• Organization, coordination and monitoring of clinical studies in accordance with ICH and GCP guidelines and internal SOPs • Recruitment, selection and training of investigators and study sites • Conducting site initiation visits, routine monitoring (on-site / remote) and close-out visits at study sites across Germany, including site communication and written documentation • Identifying on-site issues and escalating them to the study sponsor • Preparation and submission of documents to ethics committees and federal authorities, and support with correspondence • Tracking appointments and deadlines • Maintaining study data in databases (Access, Excel) • Support with submission activities / maintenance of the Trial Master File (TMF)

Job Requirements

  • Minimum 1 year of experience as a Clinical Monitor
  • Very good knowledge of ICH-GCP and the German Medicinal Products Act (AMG)
  • Strong PC skills (MS Office)
  • Good command of English, both written and spoken
  • Excellent organizational skills, independence, flexibility, reliability
  • Strong team spirit, communication skills and openness
  • Ideally, experience monitoring oncology studies

Benefits

  • Varied and interesting work in a growing company
  • Secure workplace

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