An excellent opportuity has arisen for a part time CRA to join our client, fully home based from the UK!
The ideal CRA will have the following expereince:
1.Ethics Committee Submission Experience in Sweden and Norway (preferably Denmark as well)
2.Would need to speak, read and write English, Swedish, Norwegian (preferably Danish as well)
3.Experience in either device or pharma.
The central Start-up Specialist will contribute in the proper execution of start-up, execution and study closure activities within a defined area (e.g. Region, country, etc.) in relation to clinical research conducted at study sites. The central Start-up Specialist should work in compliance with applicable national and local legislation (clinical study, medical device, data protection law, etc.), Ethical Committee (EC) policies and procedures as well as business policies.
The central Start-up Specialist is considered as the ?expert? for the planning, preparation and execution of study submission to EC. The management of EC submissions may cover the course of the study, e.g. initial submission, amendments and notifications. The central Start-up Specialist may also support activities such as the Clinical Trial Agreement (CTA) process and submission to Competent Authorities (CA), Informed Consent support, translations of study documents, facilitate internal or external meetings, work directly with sites for needed documentation and more. Activities may vary per country.
The central Start?up Specialist works under general supervision, working closely with study team, site staff, company field personnel, Country Clinical team, Regulatory, Legal, Compliance, Monitoring, Contact Analyst, Informed Consent Expert and other stakeholders as appropriate. The central Start-up Specialist may also perform Monitoring activities as needed which may include travel.
For further details about this role, please call Tim Barratt on +44(0)1717 817 626 or email email@example.com
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: BH-25907
Website: Achieva Group Limited
- Posted: 22nd July 2021
- Expires: 19th August 2021