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Clinical Research Associated (CRA) Bergen


By admin - Posted on 16 April 2015

Job position: Clinical Research Associated (CRA)

Place of work: Bergen (Norway)

About the job:
The CRA manages investigative sites, including interviewing/screening investigators and monitoring/auditing regulatory documents to ensure compliance with company SOPs, GCPs, and applicable regulatory requirements.

Education/Qualifications:
- University/college degree in Life Sciences (Medical degree preferred)
- Qualified as Senior CRA in compliance with the following three points of the Italian Decree 15-Nov-2011:
- At least 40 hours of theoretical training over the 12 months preceding the start monitoring clinical trials.
- At least 20 days of monitoring activities with an expert monitor in the previous 12 months..

This training should be performed for at least 50% of the visits at the trial centers before start-up,; The personnel training should be documented and the experience of coordinating the monitoring activities for at least 6 months in the 12 months preceding the beginning of the monior training.

A minimum 5 days of monitoring is required during the last 3 monitoring visits

- At least 4 months of monitoring activity in the previous 12 months in areas of
control and / or supervision of medicinal products and / or clinical trial, or alternatively, additional 40 days
of activities referred to in letter c) in the preceding 12 months;

Alternatively achievement of Master's degree postgraduate or graduate school or equivalent university postgraduate course in clinical trials or regulatory science or equivalent discipline, in the 36 months preceding the start monitoring;

Languages:
- English: proficient users
- Norwegian: proficient users
- French and/or German: Desirable

Experience:
- Management and Monitoring of Medical Device Trials sponsored by customers. Preparation of Ethic Committee and Ministry submissions, handling of trial master files, CRF data verifications using electronic data capture systems and conduct monitoring activities in compliance with GCP and company Standard Operating Procedures.

Personal skills:
- Capability of working in a team
- Demonstrated ability to handle multiple competing priorities;
- Demonstrated ability to inspire effective teamwork and motivate staff;
- Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with external stakeholders in a professional manner.
- Good computer skills with ability to understand and assess technology alternatives and implication for current processes.
- Willingness & ability to travel

Essential job duties:
- Monitoring: Ensure and assure the quality of the data collected on site according to ICH-GCP, SOP and study protocol
- Site Management: Identify, select, initiate and close-out investigational sites and act as liaison between study site- and the in-office team
- Study Management: Work independently and proactively to coordinate all necessary activities required to set up and monitor a study

Salary
The salary will be based on previous experience and will discussed during the job interview stage.

I look forward to your answer.

Thank you very much.

Best regards

Daniel Widmer
Executive Coordinator
Meditrial Europe Ltd.
Bellerivestrasse 11
CH-8008 Zurich
Switzerland

Mobile: 079 931 20 01
www.meditrialeurope.com