Clinical Research Coordinator with Medical and Project Management Background

Due to my work as a Clinical Research Associate, and previous as Research coordinator at the Medical University Innsbruck - Clinic for Trauma Surgery, I have relevant professional experience.

As a CRA, I mostly worked in the oncology area.

My current responsibilities include following tasks:

Consultation and training of medical and pharmaceutical staff at the clinic, the preparation, implementation and follow-up of monitoring visits (Site qualification visits, Iniation visits, Routine monitoring visits, Remote monitoring visits and close-out visits). Writing of visit report, Follow-up letter and Confirmation letter. The guarantee of training / guidance of the executing study staff at the study center. Protecting patients by verifying correctly carried out Study measures and drug administration as well as compliance to ensure compliance with applicable regulatory requirements. Ensuring data integrity on the corresponding case report Forms (CRFs) and other data collection methods through careful review of entries and source data, follow-up of implausible ones data as well as the creation of queries on customer data management systems. The time-efficient and economically efficient implementation of monitoring visits in accordance with applicable SOPs, guidelines and travel regulations.

I am familiar with ICH – GCP Guidline, EU GMP, different scientific databases like RedCap, Veeva Vault, Endpoint, Rave, Workday, KIS, Inform, Almac, dispatch of UN1845 (dry ice) and UN3373 (biological substance, category B) and EU General Data Protection Regulation.

In March 2018, I completed the Study Nurse course at the Competence Center for Clinical Trials Innsbruck and graduated with the competence certificate "Qualified Study Nurse (possibly Research Nurse)". Furthermore I studied project management at the Correspondence School of Laudius where I graduated with the mark „very good“.

Begin of October I started the master course “Clinical Research” at the Donau University Krems. I plan to finish my master thesis in March 2025.

Other qualifications:

Microsoft Office Suite

Advanced skills in Word, PowerPoint, Excel, and Outlook for documentation and presentation purposes

Emergency Medical Services

Paramedic training and mountain rescue experience providing emergency medical care. Also as dog handler on a dog resuce team.

Project Management

Project management certification and practical experience in coordinating complex medical research projects and clinical studies