Senior Clinical Research Associate - Sweden, Denmark, Finland, Norway
- Academic degree in natural science such as life sciences, pharmacy or nursing.
- At least 4 years of clinical research experience in the Pharmaceutical/CRO industry (including site initiation, monitoring and site closure).
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Good ability to express yourself both verbally and in writing
- Good knowledge of spoken and written English and local language
- Good organizational skills
- A service-minded approach
- Ability to prioritize and handle several tasks simultaneously
- Valid driving license
- Position requires occasional travel both national and internationally
- Prepare and complete applications to the regulatory authorities and ethic committees
- Responsible for completion of study documentation such as CRFs, patient diaries, QoL forms etc.
- Preparing Monitoring Manuals, Source Data Verification plans, Clinical Management Plan etc.
- Responsible for the sites and on-site management during the study process
- Drug accountability
- Participate in Audits and Inspections, Co-monitoring and Accompanied site visits.
- Select and negotiate contracts with 3rd party providers.
- Assist in data validation and clean file procedures
- Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits
- Selecting and negotiating contracts with local/central laboratories, pharmacies etc.
- Planning and participating at Investigators meeting
- Responsible for final archiving of study documents in-house and on-site