Our client, a Nordic-based CRO, is seeking a Senior CRA to be based in Stockholm or Gothenburg in Sweden. The company specialises in the areas of clinical research, data management, biostatistics and pharmacovigilance.
Job Role and Responsibilities:
- 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
Education, Skills and Experience:
- 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kristian Gustafson on +44 203 8569 337 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.