Unit for Clinial Research Office

Åsa Edfors Skutle
Leader

Clinical Research Office has 10 employees with different roles and responsibilities:

3 Project Managers coordinate clinical studies, mainly early phase I/II, at the Clinical Cancer Research Unit at the Radium Hospital

• Main sponsor (and CRO) contact in the set up phase
• Coordination of the study team across departments
• Review of the protocol, informed consent and other study documents against ICH-GCP requirements and applicable Regulations
• Consistency check across protocol with focus on logistics and administrative aspects
• Submission of clinical trials applications, amendments and reports to Ethical Committee and Competent Authorities in collaboration with sponsor and PI
• Active role in study budgeting/financial agreement and internal approval process
• Assisting in the planning and conduct of start-up meeting and regular progress meetings 
• Collection of essential documents and update of the Investigator’s Site File (CV, delegation log, insurance, approvals etc)
• Internal reporting of status and progress in clinical studies

1 Secretary working at the Clinical Cancer Research Unit at the Radium hospital

• The secretary is in charge of data entry into the electronic medical record for all patients visiting the unit
• Mail handling, telephone inquiries and other administrative duties

1 Consultant and 1 Project Consultant, located at the Cancer Center, Ullevål

• Administration and follow up of studies
• Administrative support
• Developing/ coordinating internal and external web pages for Section for Clinical Cancer Research and Resource Development
• Design and development of Case Report Forms (CRF) and collection of data
• Coordinating insurance (the Drug Liability Association) for investigators involved in clinical pharmaceutical studies working at the Department of Cancer Treatment

3 Medical Coders working at the Radium hospital, supervised by a chief physician

• Registering ICD10 codes as well as other medical codes in local databases, for all in- and out patients
• One of the employees is a registered medical nurse and is part time functioning as a research nurse

Contact Information
Clinical Research Office
Oslo University hospital
Ullernchausséen 70
NO-0310 Oslo
Tel: +47 91502770

Headed by Åsa Edfors Skutle