The NIHR BioResource for Translational Research is seeking a colleague for the Governance & Ethics team; the role holder will be responsible for ensuring the correct governance and ethics requirements are adhered to in relation to the NIHR BioResource operations and collaborations. More information on the NIHR BioResource can be found at https://bioresource.nihr.ac.uk/.
This will involve a wide range of tasks: the appointee will work closely with BioResource Coordinators both from the central team and from the individual BioResource Centres, IT and Data Scientists, Sample Teams and with sponsors and representatives of R&D of recruiting sites. The appointee will ensure that studies are undertaken in accordance with the protocols, within the boundaries of ethical and R&D approvals and in accordance with EU/UK statutory requirements and principles of Good Clinical Practice and GDPR. They will also undertake query resolution, plan monitoring activities, contribute to Information Governance duties as well as support the Governance & Ethics Manager as required.
The role holder will coordinate study activities of the NIHR BioResource for Translational Research related to ethics and governance of the research studies/Research Tissue Bank, including Information Governance, in order to ensure smooth running of the studies and regulatory compliance. The role holder will prepare and review documents for REC minor and substantial amendments, progress reports and renewals of ethics permissions.
The role holder will provide advice to researchers wishing to submit applications to use the NIHR BioResource and oversee the completion of appropriate agreements and fulfilment of contractual obligations by researchers approved in using the BioResource. They may also be involved in managing electronic consent roll out projects.
With education to degree level or equivalent experience or equivalent qualifications, ideally in a relevant subject, you will have outstanding attention to detail and meticulous data entry/monitoring skills. Experience in coordinating or managing research studies and clinical trials is essential, along with writing and submitting NHS REC applications, and obtaining HRA and R&D approval for studies. You will be able to comply with EU and UK statutory requirements and principles of Good Clinical Practice (GCP) as well as having excellent IT, communication and organisational skills.
The post is full-time and the funds for this post are available until 31st March 2022.
Location: Cambridge Biomedical Campus, Cambridge CB2 0SD (approximately 2 miles south of the city centre)
Informal enquiries can be made to Dr Sofia Papadia, Governance & Ethics Manager, email@example.com
Click the 'Apply' button below to register an account with our recruitment system (if you have not already) and apply online.
Closing date: 8th September 2019
Interview Date: w/c 16th September 2019
Please ensure that you upload a covering letter and CV in the Upload section of the online application. The covering letter should outline how you match the criteria for the post and why you are applying for this role. If you upload any additional documents which have not been requested, we will not be able to consider these as part of your application.
Please include details of your referees, including email address and phone number, one of which must be your most recent line manager.
Please quote reference RH20079 on your application and in any correspondence about this vacancy.
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