Steinthora Thorisdottir Email & Phone Number

Iceland

Garðabær, Capital Region, Iceland

Kópavogur, Capital Region, Iceland

Reykjavik, Iceland

Hringbraut, Reykjavik, Iceland

Horgatun 2, 210 Gardabaer, Iceland

• As an RAS - Managing and performing activities within the department of Clinical Operations, including but not limited to:
• Preparation and submission of Clinical Trial Authorisation requests, amendments and notifications to regulatory bodies in Iceland
• Correspondence with sponsor, investigators and regulatory, ethics and data protection agencies for regulatory activities
• Translation of regulatory documents
• Participation in development of quality/procedural documents applicable to company/department operations and assisting in training of new employeesAs a CRA - Monitoring the conduct of clinical studies for compliance.
• Project preparation and start up of clinical studies, including supporting preparation and submission of the request for clinical trial authorisation

Horgatun 2, 210 Gardabaer, Iceland

• Monitoring the conduct of clinical studies for compliance with the protocol, ICH Good Clinical Practice and applicable laws and regulations. Serve as main line of communications between sponsor and investigator sites.
• Project preparation and start up of clinical studies, including supporting preparation and submission of the request for clinical trial authorisation
• Participating in developing monitoring plans
• Preparing, conducting and reporting monitoring visits to site
• Prepare and present at initiation meetings and other training
• Participation in development of quality/procedural documents applicable to company/department operations and assisting in training of new employees

Preparation and submission of Clinical Trial Authorisation requests, amendments and notifications to regulatory bodies in IcelandCorrespondence with sponsor, investigators and regulatory, ethics and data protection agencies for regulatory activitiesTranslation of regulatory documentsParticipation in development of quality/procedural documents applicable to.

Project preparation and start up of clinical studies, including supporting preparation and submission of the request for clinical trial authorisationParticipating in developing monitoring plansPreparing, conducting and reporting monitoring visits to sitePrepare and present at initiation meetings and other trainingParticipation in development of.

Clinical Chemistry And Hematology Laboratory

Heamatology, urinalysis and analysing of other body fluids

Division of Inflammatory diseases: Histology, RNA isolation from fresh frozen tissueDrug Discovery division: Histology, In-Situ HybridisationCardio-Vascular Division: Genetics, DNA isolation, genotyping, sequencing etc.Bone Division: Genetics, DNA isolation, genotyping, sequencing etc.CNS division Genetics, DNA isolation, genotyping, sequencing etc.

M.Sc., Health Sciences

M.Sc degree in Health Sciences with emphases on pathology and genetics. My M.Sc essay was entitled: Expression of EP2 and EP3.

Bachelor Of Science (Bsc), Biomedical Sciences

B.Sc degree as a Biomedical Scientist with emphasis on Pathology and Heamatology. My B.Sc essay was about embedding bonemarrow samples in.

Matriculation Degree, Science

Matriculation degree with emphasis on science