Clinical Trials Officer - Bristol, United Kingdom - North Bristol NHS Trust

North Bristol NHS Trust

Verified Company

Bristol, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

North Bristol Trust is seeking to recruit to an important and exciting role within Research & Development department as a Clinical Trials Officer Band 6.

The clinical trials officer role sits within our sponsorship team, whose function is to have oversight for all NBT sponsored research studies.

The role will involve conducting appropriate risk assessments and identifying risk mitigations of proposed research studies.

The post holder will provide ongoing support to researchers in preparation for HRA submissions and will also be responsible for maintaining ongoing oversight of the study throughout its delivery.

In the role you will promote and develop a research culture that supports high quality research by helping and supporting research leaders and their teams.

We are looking for someone who has relevant experience of managing research within healthcare settings with up-to-date knowledge and understanding of local and UK regulatory requirements relating to research, as well as someone who enjoys collaborating and providing support to a variety of different people.

You will need to be a good communicator and be diligent, showing attention to detail, whilst being a proactive problem solver.

If you think this is you and you are looking for a new challenge working as part of a friendly team then please get in touch to find out more and have an informal chat about the role.

The post holder is required to provide support to the Research Compliance Manager to implement systems and standard operating procedures to support and monitor clinical research studies within the organisation in line with the current UK Policy Framework for Health and Social Care, the Medicines for Human Use (Clinical Trials) Regulations (2004), ISO 14155 and any subsequent amendments and ICH - GCP regulations.

The post holder will be responsible for ensuring appropriate assessment of the risks to NBT when acting as sponsor for research studies.

The post holder will be responsible for monitoring the quality of research, by attending regular meetings with the research team and conducting risk-based monitoring visits.

The Clinical Trials Officer (CTO) will need to monitor the data produced, as well as participant safety and experience.

The CTO will be responsible for facilitating trial set-up, by supporting the research facilitation team and wider teams to ensure efficient set up whilst meeting required standards and regulatory requirements.

The CTO will be responsible for the quality of data maintained within R&D database.

The CTO will act as a resource regarding study delivery, SOP development, Pharmacovigilance, and training.

The CTO will be expected to work in a team and resolve complex issues around research collaboration, material and data transfer and handling of samples as per the guidelines provided by the framework of health and social care.

The role is based within the successful & welcoming Research & Development (R&D) team at North Bristol NHS Trust.

Working alongside the 170 plus departmental staff you will have the opportunity to network with other researchers and have access to our supportive training and development structure.

The R&D team have been awarded the Investors in People Silver Award , making it a great place to work.

North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead.

We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities.

Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.

We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services.

North Bristol NHS Trust values all people as individuals.

We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

We welcome applicants from all underrepresented groups.

Please review the job descrition for more detailed information regarding main responsibilities:

Ares of key responsibilities relate to the following areas:
Clinical trial set up and running

Reviewing research proposals and associated study documentation, appraise risk and undertake sposnorship review on behalf of NBT. Working with stakeholders to ensure all governance and regulatory checks have been carried out prior to R&D approvals.

Overseeing study delivery and ensure research compliance and reporting is adhered to

Performance management.

Oversee performance of NBT sponsored studeies working with stakeholders to identify and address poor recruitment.

Be responsible for fulfulling the trust monitoring obligations in line with the Reesarch Governance