Clinical Project Assistant
Clinical Trial Assistant - Stuttgart Region Germany
Start Date: January 2019
TalentSource Life Sciences, a division of CROMSOURCE, is looking for a Clinical Trial Assistant (CTA) to strengthen our team at one of our Medical Devices clients located in the greater Stuttgart Area in Germany.
The Clinical Trial Assistant will take the full responsibility of 3 to 6 clinical trials and works with both the Clinical Project Managers and all Clinical Research Associates (CRA's).
CTA's act as backup during absence of other colleagues. Main duties are to assure the secretarial administration for clinical studies, managed in Germany and Europe wide.
- Bachelor degree preferably in Life Sciences
- CRA Training
- Written and spoken knowledge of German and English
- Knowledge of regulatory requirements for clinical trial applications in the EU and DE is an asset
- Good knowledge of MS Office
- Easy in managing flows of information, communication, documents and material
- Ability to work with multiple interlocutors and managers and set priorities
- Provide administrative support to the Project Managers and the Clinical Research Associates
- Correspondence: letters, e-mails, reports, internal correspondence…
- pre-approval/ pre-FVFP (inclusion of first study patient): preparation of trial application documents, translation of patient information & informed consent documents, FU of regulatory submission files and organization of study start-up meetings and files (creating binders and other docs)
- post-FVFP': ongoing recruitment and patient FU, assist monitors in redaction of post-monitoring letters, study document updates, submission of protocol amendments, tracking of study material, manage Sponsor Study File, as well as end of study tasks, such as archiving of documents.
- Phone and e-mail contacts: mainly with the Ethics Committees, Investigators and hospital staff
- Prepare, submit and follow-up of Clinical Trial Applications
- Prepare the Investigator Study File & Study Initiation Visit
- Manager the Sponsor Study File, file and archive documents, including the tracking of the documents
- Create and maintain study-specific contact lists & checklists
- Translate study related documents
- Logistic follow-up of study medication & material
- Guarantee of the use of correct language and house style
- Assist in the planning and organization of Investigator Meetings and other study related events
- Attend internal meetings
If you have the experience needed for this position, please contact Vanessa Verdickt, Consultant TalentSource Life Sciences Unit, and send your CV in Word format to firstname.lastname@example.org
Why TalentSource Life Sciences/CROMSOURCE
Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Keywords: Clinical Trial Assistant, languages, translations, ICH-GCP, Clinical studies Support
Clinical Project Assistant, Clinical Research Assistant, Clinical Trial Assistant, Project Assistant