Finsktalande Klinisk Prövningsledare/ CRA

For our[client we are now looking for a CRA.You will work towards the finnish market and therefore we want you to be able to speak finnish.General description The Clinical Research Associate will work operationally as a member of the Study Team and is responsible for the initiation, monitoring and termination of tasks during the study process, according to company/sponsor policies, SOPs and regulatory requirements.Essential Job Functions * Contribute to the completion of the application to ethics committee, prepare all necessary documentation enclosed to the application according to local requirements. * Contribute to the completion of study documentation material such as: CRFs, patient diaries, study participation cards, QoL-forms. * Contribute to the preparation of study documents such as: Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual. * Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits * Responsible for the site(s) and on-site management during the study * Set up ISF in cooperation with CTA * Maintain ISF at site * Maintain SMF in cooperation with the study team * Ordering and coordination of study supplies on site * Prepare study documentation and assist the Clinical Quality Assurance Manager/regulatory authorities during audits/inspections in-house or on site * Negotiate contracts with local/central laboratory(ies)/pharmacy etc * Responsible for site status reporting to Lead CRA/CRM * In cooperation with study team, responsible for the archiving process * Participate in Investigator's meeting(s) * Contribute to training and mentoring of new CRA and CTA Actively contribute to the organisation and development of routines to enhance the work at our client/sponsor.