Karolinska Universitetssjukhuset, Högspecialiserad barnmedicin 1

This is a great opportunity to join Karolinska University Hospital and work in clinical research!

Position Summary

As Clinical Trial Assistant (CTA) you will work with an international multi-center clinical study (ALLTogether1) supporting the Trial Central Office (Global Clinical Trial Manager, a Regulatory specialist and Chief investigator) and the Data Management Team with administrative support.

The study is based on a Consortium including over 140 pediatric oncology and adult hematology clinics in 14 European countries, who will participate in the trial. The Sponsor of the clinical study is Karolinska University Hospital and the Trial Central Office and the data-management team is placed in offices close to the Sponsor in Solna, Sweden. The clinical indication of the study is Acute Lymphoblastic Leukaemia (ALL) in children and young adults.

Main Responsibilities

  • Provide general administrative support to the Trial Central Office and Data Management
  • Assist Regulatory work (preparation of applications for regulatory and ethical approval)
  • Assist the Trial Central Office in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports included in the Trial Master File according to laws, regulations, ICH-GCP and internal standard operating procedures (SOPs)
  • Check and forward incoming correspondence
  • Assist in the preparation of budgets and management of invoices and payments
  • Perform administrative tasks to support Consortium team members
  • Assist the Trial Central Office with Meeting coordination and preparation of related activities
  • Assist the Study Data Management Team with data management activities/tasks
  • Assist in the set-up, updates of SOPs
  • Produce administrative SOPs
  • Updating and maintaining the ALLTogether web portal
  • Assist in preparation of internal/external audits
  • The work will involve comprehensive in-house protocol training

Qualifications

Required Knowledge, Skills, and Experience:

  • University degree in life sciences or country's educational equivalent
  • Administrative support experience; or equivalent combination of education, training and experience
  • Relevant work experience from clinical research or examination from “Klinisk läkemedelsutveckling 30 hp, CDD” at Uppsala University or equivalent
  • Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
  • Proficient in written and spoken English. Fluent in Swedish language preferred
  • Ability to establish and maintain effective working relationships with co-workers and collaborators in the trial
  • Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
  • Thrive in both individual and team settings
  • Be driven, well-organised, detail oriented and with  good coordination and communication skills
  • Be willing to perform a variety of tasks within the clinical trial workflow

Applications

If you are interested in joining our team, please register the following documentation:

  • Cover letter expressing your interest in the position
  • Resumé

We will begin considering applications immediately. The position will remain open until the right candidate is found.

 

Type of employment Permanent position
Contract type Full time
First day of employment enligt överenskommelse
Salary Månadslön
Number of positions 1
Working hours 100%
City Solna
County Stockholms län
Country Sweden
Reference number 2022/5640
Contact
  • Nina Perrin, 08-58587313
  • Karin Flood, 0703214922
Union representative
  • SACO; Tony Frisk , tony.frisk@regionstockholm.se
  • Vårdförbundet ; Louise Kjellkvist, Louise.kjellkvist@regionstockholm.se
  • Kommunal; Saddhani Lundström, Saddhani.lundström@regionstockholm.se
  • Vision; Katarina Wennmark, Katarina.wennmark@regionstocholm.se
Published 03.Aug.2022
Last application date 23.Aug.2022 11:59 PM CEST
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