Covance is currently seeking a pro-active Clinical Research Assistant to join our expanding team in Stockholm. This is a client-dedicated role to be office based in Stockholm and ideally you will have at least 1-2 years experience of supporting Clinical Trials in Sweden. Much of the work will involve complex Oncological Clinical Trials and so there is plenty of interesting (and worth while) work to get your teeth stuck into!
Essential Job Duties:
- Act as contact for project team and study sites
- Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on management systems
- Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
- Assist with the management of study supplies and organize shipments
- Create, update, track, and maintain study-specific trial management files, tools, and systems.
- Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings)
- Coordinate meetings with clients, investigators, and project team, including taking minutes.
- Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
- Provide input in writing Monitoring Conventions as assigned
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
- General On-Site Monitoring Responsibilities:
- Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
Other Information: This role is a full time & permanent position to be employed through Covance. For more information please contact Andy Smith at Covance on +44 (0)7775 848 250 or mail firstname.lastname@example.org
Key words: CTA, Clinical Trial Administrator Sweden, Stockholm, GCP, CRO, Pharmaceutical, Clinical Administration Sweden CTA, OncologyEducation/Qualifications:
A degree ideally but not essentialExperience:
1-2 years in Clinical Trials in Sweden
Fluency in Swedish (essential)
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