Project Assistant / Study Assistant (m/f/d) (Project Assistant)

To support our rapidly growing team, we are looking for the earliest possible date: Project Assistant / Study Assistant (m/f/d)

Internal Medicine - GHSG Studienzentrale TV-L 38.5 hours/week, limited to 1 year Remuneration according to TV-L up to EG 6

Your Tasks

• Support the project manager with arising tasks in the field of clinical trials from Phases I to III
• Design and creation of study folders, such as

Trial Master File (TMF), Investigator Site File (ISF) and patient files

• Requesting, recording, checking and providing study documents for submissions or for filing in the TMF/ISF
• Management of TMFs, including maintenance of overview tables to ensure the completeness of the TMF
• Preparation of the regulatory release of the investigational medication (Sponsor release)
• Management of study-specific training documentation of the study team as well as

checking for completeness

• Organization of shipping for ISFs, lab kits or other study materials and documents
• Contact and address management in the database
• Requesting, recording, checking and tracking of closing documents upon completion of the study as well as the archiving of TMFs

Your Profile

• Training in a scientific,

pharmaceutical or medical field (e.g. nursing, MTA, PTA etc.) or as a Medical Documentarian

• Ideally initial experience in conducting clinical trials
• Experience in using IT software (especially Word, Excel, Outlook, Power Point, electronic data capture)
• Good knowledge of the English language

Your Advantages

• Everything, except ordinary: You can expect a secure and meaningful job in a demanding work environment where you are always at the cutting edge.
• Job and private life in harmony: Thanks to the flexible working time account and preferred schedules, you have more time for hobbies, family and friends.
• Team spirit in R(h)einkultur: You will be welcomed with open arms by an interdisciplinary team that values mutual appreciation and helpfulness.
• Strong perspectives: What others gather through various stages of experience, we offer under one roof as one of the largest employers in the region – so you can grow beyond yourself and aim for new goals.

Your future with us We are one of the leading university hospitals in Germany and network research, teaching and patient care at a top level. That is why many things with us are a step larger: the spectrum of exciting development opportunities. The boundless openness with which specialists from all over the world work together here. Or our commitment as an employer to support all employees as best we can in balancing their profession with their goals and life situations. This is Uniklinik Köln: Everything, except ordinary.

Your future in detail The German Hodgkin Study Group (GHSG) under the leadership of Professor Dr. Peter Borchmann is the world-leading research group in the field of Hodgkin lymphoma. For 40 years, the results of multicenter clinical trials have contributed significantly to the continuous improvement of the prognosis for patients with Hodgkin lymphoma. The GHSG is a member of the Kompetenznetz Maligne Lymphome. As the Studienzentrale of the GHSG (Head Mr. Michael Fuchs), we are organizationally assigned to the Klinik I for Innere Medizin of the Universität zu Köln. Our tasks are planning, preparation, organization, implementation and evaluation of GHSG studies as well as systematic analyses using our study database with over 20,000 patients. In our team, various areas such as medicine, statistics, data management, project and quality management and programming work closely together. The Project Assistant area supports the project management. People with disabilities are welcome and will be given preference if they have equal suitability and qualification.

People with disabilities are welcome and will be given preference if they have equal suitability and qualification. The work area is generally suitable for filling with part-time staff.

Contact Ineke Oosterhaar Universitätsklinikum Köln AöR Geschäftsbereich Personal Kerpener Str. 62 50937 Köln

Uniklinik Köln Career Application deadline: no deadline Job-ID: 51f24o1e We look forward to your application and to getting to know you!