Promotion: Biologie

2/2017 – 8/2017

- Perform QC of documents submitted to the eTMF
- As needed assist study teams with document scanning and uploading for eTMF
- Address questions pertaining to how documents are filed in the eTMF for users
- Assist with capturing the identified TMF metrics for the eTMF
- Perform ad hoc archiving tasks
- Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions.
- Foster communication with management throughout the organization to promote increased cooperation and accountability for results.
- Work closely with the study file management group and study teams

Klinische Studie

12/2015 – 11/2016

- Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.
- Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
- May perform assigned administrative tasks to support team members with clinical trial execution.

Klinische Studie, Klinische Monitor (CRA)

9/2015 – 11/2015

- Clinical Monitoring Processes
- In-House Site Management
- Support of startup activities at the Regulatory Startup department

Klinische Monitor (CRA)