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Research Governance Trial Co-ordinator

Employer
Royal Papworth Hospital NHS Foundation Trust
Location
Cambridge Bio Medical Campus
Salary
£28,407 to £34,581 a year
Closing date
12 Mar 2024

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An exciting opportunity to work as a Research Governance Trial Co-ordinator has arisen in the Research and Development (R& D) Team at Royal Papworth Hospital NHS Foundation Trust. You will be based at the Heart and Lung Research Institute (HLRI) at Royal Papworth Hospital on the Cambridge Biomedical Campus.

We are a team of experienced and dedicated professionals collaborating with our talented multi-disciplinary clinical teams to deliver a wide range of innovative high quality research trials to inform the future care of our patients. The R& D team support a large and growing portfolio of trials across multiple specialities.

We offer a friendly working environment and are interested in your career development with a range of training opportunities available to help you fulfil your potential.

We are looking to appoint an enthusiastic, motivated, and proactive individual who will enjoy the challenge of Research Trial set up, managing, and regularly updating databases, monitoring data quality, and producing reports which are complete and accurate for the Trust and NIHR Clinical Research Network (CRN). This requires working closely with research staff and a wide variety of other external and internal stakeholders.

The post holder will also be responsible for completing local governance checks for research trials and projects that are being set up or delivered at the Trust. This includes processing regulatory amendments for implementation at the Trust.

Main duties of the job

As an essential member of the Research Governance Team, you will be responsible for the management of the electronic research database, including regularly updating and performing Quality Assurance/Quality Control checks, in conjunction with the Senior R& D Manager and Research Governance Team.

Be responsible for conducting local governance checks and for processing regulatory amendments for implementation at Site within the required timeframe.

Assist with successful management of research trials in set up and through the feasibility and capacity and capability review process. These will include commercial and non-commercial trials and Papworth Sponsored trials.

Assist with the review of trial documents to assess risk, impact, Trust Capacity & Capability, and ensure compliance to regulatory requirements.

You will provide support in achieving specified milestones on trial set up and release of capacity and capability and support the clinical research team to ensure the trial is being conducted according to the ethically approved protocol and ICH-GCP standards.

Provide advice and assistance as needed on the use and implementation of our LPMS (Edge) to research teams across the Trust.

About us

Royal Papworth Hospital NHS Foundation Trust is the UK's leading heart and lung hospital, delivering care to more than 50,000 patients a year in its new state-of-the-art hospital in Cambridge. We perform the most heart and/or lung transplants in the UK and carried out the UK's first successful heart transplant in 1979. It also offers emergency heart attack treatment, sleep centre care and is one of just five centres nationally for those in severe respiratory failure.

Based on the Cambridge Biomedical Campus the largest centre of medical research and health science in Europe the Trust is at the heart of treatments of the future. Royal Papworth became the first hospital trust in the country to be rated outstanding in all five areas assessed by the Care Quality Commission - a rating it still holds today. The Trust holds its values of compassion, excellence & collaboration at its core, and all colleagues joining the team are expected to uphold these in their day-to-day roles & interactions. Royal Papworth is proud of its diverse workforce and encourages people to embrace their individuality.

The Trust values difference and welcomes all applications irrespective of age, disability, gender reassignment, marriage and civil partnership, pregnancy & maternity, race, religion & belief, sex and sexual orientation. Providing they meet the minimum post criteria, applicants with disabilities will be offered an interview.

For a street view tour: https://royalpapworth.nhs.uk/virtual-tour

Job description

Job responsibilities

On this page you will find a Role Profile which provides information about the hospital and full details about the role. We recommend that you review this and refer to it as you complete your application. Please include how you will meet the Trust Values Compassion, Excellence and Collaboration. If you would like more information about the role or working at Royal Papworth Hospital, please get in touch with the contact for this role.

Person Specification

Qualifications

Essential

  • Education to at least A level standard.
  • Willingness to maintain and update skills, including attendance of courses on and off site.


Desirable

  • Professional knowledge acquired through degree or equivalent qualification or experience.
  • ICH GCP Training


Experience

Essential

  • Experience using a research-related database.
  • An excellent understanding on use of computers and a demonstrable ability to learn to use new computing systems and data processing tools rapidly and accurately.
  • Experience of preparing reports for internal and external review.
  • Understanding and knowledge of improving and maintaining Data Quality.
  • Ability to communicate clearly to both technical and non-technical colleagues and knowing how to keep information concise but complete.
  • Excellent written and verbal communication skills in relation to research studies.
  • Ability to organise and prioritise their own work within tight deadlines and methodical in approach, with effective problem-solving ability.
  • Ability to work across boundaries and multi-disciplinary teams.
  • Able to establish positive working relationships with a range of health care professionals.
  • Awareness and understanding of Information Governance and GDPR guidelines and ability to treat hospital information confidentially.
  • Ability to deal with complex and
  • challenging situations and adapt quickly to change.


Desirable

  • Experience using EDGE.
  • Experience working in a clinical trials, research, or governance setting including data entry.
  • Experience in managing complex or large relational databases.
  • Good understanding of Data Protection legislation
  • Understanding of overall database design, software implementation and related business processes
  • Good analysis skills and be able to work closely with the project teams to identify their reporting requirements.
  • Good knowledge of ICH GCP requirements and information governance.


Additional Criteria

Essential

  • Please provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, Collaboration


Employer details

Employer name

Royal Papworth Hospital NHS Foundation Trust

Address

Heart and Lung Research Institute

Papworth Road

Cambridge Bio Medical Campus

Cambridge

CB2 0AY

Any attachments will be accessible after you click to apply.

175-2324-2-RD448

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