Finsktalande Klinisk Prövningsledare/ CRA
Randstad AB Stockholm / Apotekarjobb / Stockholm
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Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige 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.
Please contact Joacim Älgevik on 08-693 94 07 if you have any questions regarding the position.
Publiceringsdatum2010-12-15Arbetstider och omfattningHeltid
ErsättningEnligt ö.k
Så ansöker duSista dag att ansöka är 2011-01-13
Ansökan kan tyvärr inte göras via e-post.
Ansökan sker via företagets webbplats.
KontaktJoacim Carlsson, 08-693 94 00
FöretagRandstad AB Stockholm
AdressRandstad AB Stockholm
Box 17193
10462 Stockholm
Jobbnummer 802107
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