Since January 2015
Site ID Services Specialist
July 2014 --- January 2015
-To manage Capability, Feasibility and Site ID opportunities for Finland, Sweden, Norway and Denmark, identify potential new sites - Distribute, track, negotiate and review the Confidential Disclosure Agreements - Review Site Identification Forms for site capability and suitability of investigators - Collect, review and reconcile country Feasibility / Site Identification data - Maintain and update information repositories and databases.
Feasibility/ Site ID Specialist
April 2012 --- June 2014
- Taking responsibility of local capability exercises and larger feasibility projects -Perform, manage and coordinate activities associated with identification of sites for projects -Maintain and update departmental information repositories and databases - Assist in collecting and reviewing documents for investigational product release.
Clinical Trial Assistant (CTA)
June 2011 --- April 2012
- Maintain unit and clinical trial files (eTMF) - Collection, tracking, verification and appropriate dissemination/distribution of essential documents - Organisation of all translations in local language, when required, of all study related documents - Release investigational product to investigators - Coordinate return and destruction of unused clinical supply - Requisition of study-related payments.
May 2007 --- May 2011
- Responsible of quality management system - Assist in GCP audits - Source Data Verification - GLP audits in Europe - GCP and GLP training
Engineer of Biotechnology
September 2008 --- March 2009
- Writing and developing test protocols for microbiological tests - General laboratory work.
September 2002 --- December 2004
Nurse, in different wards. - Responsible of pharmaceuticals at psychiatric ward.
May 2002 --- September 2002
Nurse in neurological rehabilitation ward.
Skills and Expertise
Build and manage the Trial Master File (TMF) Create SOPs Guide students Interact with nurses Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsAdminister logisticsAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdministrative supportAdverse event reportingArchive documentationArchive study documentsArchive trial documentation and correspondence.Aseptic techniquesAssess site feasibilityAssess subject safetyAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingBuild trial master file (TMF)Coach and provide guidance to clinical staff.Collaborate with medical teamCollaborate with project teamCollaborate with principal investigatorCommunicate with sponsorCommunication
Bachelor's Degree in Engineer of Biotechnology from Turku University of Applied Sciences in 2008
Bachelor's Degree in Registered Nursing/Registered Nurse from Turku University of Applied Sciences in 2001
Training and Certification
CRA EAPA Bridge Program in 2016 Training