- Provide general administrative support to TCO and the Data Management Team.
- Assist with updating and maintaining systems/files/contact lists.
- Assist in regulatory work (applications in CTIS, ethical review authority, and biobank).
- Be responsible for the Trial Master File, i.e., preparation, handling, distribution, and archiving of clinical documentation and reports included in the Trial Master File according to laws, regulations, ICH-GCP, and internal standard procedures (SOPs).
- Check and forward incoming correspondence.
- Assist in handling and archiving invoices and payments.
- Perform administrative tasks to support Consortium group members.
- Assist TCO in meeting coordination and related activity preparation.
- Assist/be responsible for updating SOPs.
- Develop administrative SOPs.
- Support the Data Management team.
- Update and maintain the web portal for the ALLTogether1 study.
- The work will involve extensive internal protocol training.
- University degree in natural sciences or equivalent relevant combination of education, internships, and experience.
- Fluency in Swedish (spoken and written) and excellent English language skills (spoken and written).
- Good knowledge of regulatory requirements for clinical research; i.e., Good Clinical Practice (GCP) guidelines and International Conference on Harmonization (ICH).
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Work experience in clinical trials.
- Ability to establish and maintain effective work relationships with colleagues.
- Strong organizational skills.
- Ability to handle multiple tasks simultaneously, accuracy, and attention to detail.
- You enjoy working both independently and as part of a team.
- You should be open to performing various tasks in the ongoing work with ALLTogether1.
- Adapts easily to changing circumstances, can quickly change perspectives and attitudes, and sees opportunities in changes.
- Plans, organizes, and prioritizes work efficiently. You set and meet deadlines.
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Clinical Trial Assistant - Stockholm, Sverige - Karolinska
Beskrivning
Clinical Trial Assistant (CTA) at Karolinska University Hospital
A unique opportunity to start working at Karolinska University Hospital in clinical research. Welcome to apply with us.
You are offered
As a Clinical Trial Assistant (CTA), you will work in a clinical international multicenter study (ALLTogether1). CTA will be part of the team "Trial Central Office" (TCO) including a Global Clinical Trial Manager, a regulatory specialist, and our Chief investigator.
The role primarily involves providing administrative support to TCO and our Data Management Team. The study is based on a consortium with pediatric oncology and hematology clinics for adults in 14 European countries. The clinical study sponsor is Karolinska University Hospital, and TCO and Data Management team work from an office close to the sponsor in Solna, Sweden. The clinical indication for the study is Acute Lymphoblastic Leukemia (ALL) in children and young adults.
You will, of course, also be able to enjoy what Karolinska University Hospital offers you.
About the position
The position is based in Stockholm, Sweden. Some tasks can be performed remotely, but the majority of the work is expected to be done in the office. Your tasks will include:
Qualifications
Requirements:
Preferred:
We are looking for someone who
About the recruitment process
Selection will be ongoing, and the position may be filled before the application deadline, so do not wait with your application.
Welcome with your application - Together we are Karolinska
Before filling a position that involves caring for children and adolescents, the candidate offered the position will undergo checks against the suspicion and criminal records. Learn more about the recruitment process and the checks carried out at Karolinska.
About Karolinska University Hospital
We at Karolinska University Hospital are proud to be one of the world's leading university hospitals. In addition to our special responsibility for highly specialized care in the Stockholm region, the main mission is to educate future healthcare professionals together with Karolinska Institutet and conduct world-leading research while continuing our work to develop healthcare for the benefit of patients. We work in a variety of areas and professions.
Our vision - We will cure and relieve tomorrow what no one can cure and relieve today.
Read more about us and follow us on social media.
Theme Children - Astrid Lindgren Children's Hospital
At the Children's Theme - Astrid Lindgren Children's Hospital, neonatal children and severely ill children with chronic diseases, congenital malformations, and various acute conditions from all over the country are welcomed.