Clinical Trials Assistant (CTA) - sponsor dedicated
- Germany
- Clinical Trial Support
- ICON Strategic Solutions
TA Business Partner
- Full Service Division
About the role
The Clinical Trials Assistant (CTA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
- Assists in coordination and administration of clinical studies from the start-up to execution and close out
- Collects, assists in preparation, reviews, and tracks documents for the application process.
- Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
- Previous administrative experience preferably in the medical/ life science field.
- Proven organizational and administrative skills.
- Computer proficiency.
- Good knowledge of spoken and written German and English
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
Teaser label
Inside ICONContent type
BlogsPublish date
10/03/2022
Summary
In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-pe
Teaser label
Inside ICONContent type
BlogsPublish date
05/22/2022
Summary
Having enjoyed steady growth over the last several years, it’s predicted that the global clinical trials market will hit a value of $65.2 billion by 2025, and around 58% of this can be attributed to r
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