Nancy Hofmann

Verantwortlich für die Vorsorgeuntersuchungen, Labor, Empfang, Lungenfunktion,

develops and maintains a close and collaborative communication with the site staff. Actively discuss protocol conduction, enrollment rates and strategies, open issues, EDCcompletion and queries, as well as any other topic or indicator associated to project status and site performance. Follow up for subject data in the EDC and other applicable systems.

Davon 1 Jahr Sabbatical develops and maintains a close and collaborative communication with the site staff. Actively discuss protocol conduction, enrollment rates and strategies, open issues, EDCcompletion and queries, as well as any other topic or indicator associated to project status and site performance. Follow up for subject data in the EDC and other applicable systems.

CRA in different international clinical phase studies in Germany and Austria, assessing the suitability of investigator sites, responsible for site management from initiation to close-out, built relationship with investigators and site staff, performed on-site visits in accordance with the monitoring plan

Clinical Research Associate

Medical and Safety Reviewer, SAE Management, In-house-Monitoring of Case Report Forms to assure all safety parameters were captured, worked as part of the clinical team to assure the patient/ study drug safety data was received, generated all safety queries, query resolution, collecting and reporting SAE’s to pharmacovigilance and guiding data management in data reconciliation.

Supports the study management within the scope of clinical pharmacology - Contact person for study coordinator regarding queries for scheduling, organisation and performance of the studies - Collaboration regarding preparation and updating SOPs - involved in audit’s - independent performance of study specific tasks according to the study protocol - responsible for transmission of the CRFs on schedule and collaboration with Datamangement regarding queries, query management and query resolution.