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Clinical Trials Coordinator

Requisition ID:  1062
Location: 

Newcastle, GB

Contract Type:  Fixed Term
Posted Date:  06-Nov-2019

 

We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.

Salary: £30,942 to £32,817

Closing Date: 20 November 2019

 

 

An exciting opportunity has arisen for an experienced Clinical Trials Coordinator to cover maternity leave. The post will be based in both the Clinical Research Facility (CRF), at the Royal Victoria Hospital and the Clinical Ageing Research Unit (CARU) at the Campus for Ageing and Vitality.

The post holder will take responsibility for a portfolio of multi-disciplinary clinical trials (both commercial and non-commercial). The primary responsibility of the post is to ensure the smooth running of each study in the post holder’s portfolio, ensuring compliance with local and national guidance and legislation.

Clinical Trial Coordinators are the lynchpins of the clinical trial process. This is a role that requires the post holder to have a broad range of skills with a need to be flexible, reliable and efficient. The successful candidate will be educated to degree level (or have relevant vocational experience), have excellent communication skills and extensive administrative experience.

This is a full time post to start in January 2020 for approximately 12 months.

If you have any queries about this post please contact Mandy Jarvis, Operations Manager via email (mandy.jarvis@ncl.ac.uk). 

Further information about the CRF and CARU can be found via the following links:  https://www.ncl.ac.uk/crf/rvi/about/ and https://www.ncl.ac.uk/caru/about/

 

The Role

The main purpose of this role is to take responsibility for a portfolio of multi-disciplinary clinical trials, both commercial and non-commercial, for the CRF/CARU. Collate and manage regulatory documentation to ensure that CRF/CARU (working on behalf of University and Trust Personnel) is conducting research in accordance with UK regulations and local guidance. You will manage projects professionally and in accordance with relevant regulations from first customer contact through to archival of project documentation; providing evidence demonstrating that the research conducted in the CRF/CARU safeguards the wellbeing of patients and produces credible data.

 

Key Accountabilities

  • Liaise with all parties to ensure the smooth start-up of studies, ensuring that all regulatory, ethics and other applicable approvals are obtained
  • Manage and monitor documentation relevant to regulatory, ethics and other applicable approvals and ensure proactive communication with sponsors
  • Ensure relevant internal parties are advised of new studies and their progress through to active status through timely communication
  • Organise and coordinate feasibility/site selection meetings
  • Provide input at the feasibility/design stage of a trial in relation to CRF/CARU capabilities and resources, utilising research experience and initiative
  • Initial assessment of protocols to consider resource, logistical and budget implications
  • Liaise with the Senior Research Sister and site Director to assess suitability of studies for CRF/CARU
  • Prepare costings for clinical trials (and subsequent amendments) and Grant applications, and facilitate negotiation with the funder representative
  • Review Clinical Trial Contracts with a view to ensuring the budgetary aspects, targets and timelines reflect what has been negotiated and agreed
  • Prepare and track submissions for local approvals to University/Trust Research offices
  • Ensure all essential documents are in place before any study commences or participants are recruited
  • Prepare submissions of protocol amendments for local R&D confirmation of capacity and capability
  • Preparation for and facilitation of audits and/or inspections
  • Ensure archival of essential documents in accordance with local policy
  • Maintain and update the project database to ensure swift reporting of status
  • Present and discuss CRF/CARU project status at internal meetings, including regular meetings with University and Trust Research offices and Pharmacy personnel
  • Ensure regular payments are made by sponsors, checking that the payments are an accurate reflection of the trials budget specified in the Clinical Trials Agreement with the sponsor and maintaining records of payments made
  • Organise, attend and document meetings or training events relevant to the start-up, conduct or closure of trials
  • Provide guidance and support for Principal Investigators, sharing knowledge of best practice and current legislation/guidance
  • Use initiative and judgement in day to day management of workload and problem solving
  • Take responsibility for continuous improvement of yourself and of research administrative processes and target achievement, in line with changing regulations in clinical research and Faculty strategy
  • Sharing knowledge with CRF/CARU nursing team and new researchers
  • Undertake other reasonable duties or responsibilities as requested
  • Contribute to the completion of various reports (e.g. NIHR annual report)
  • Supervision of professional support staff within the research team
  • Be aware of and take responsibility for working in accordance with applicable regulations and guidance regarding the conduct of clinical trials

 

The Person

Knowledge, Skills and Experience

 

Essential

  • Ability to comprehend the basic science behind research projects in different therapeutic areas
  • Microsoft office applications including the use of internet and email
  • Excellent organisation and time management skills
  • Able to communicate clearly and concisely in writing
  • Experience of clinical research
  • Experience of managing or coordinating a project

Desirable

  • A background in science
  • Ability to construct and maintain spreadsheets and databases
  • Experience of preparing submissions of research projects to an ethics committee
  • Experience of costing a project
  • Experience of tracking documents
  • Understanding of ethical issues surrounding research and patients
  • Understanding of medical terminology
     

Attributes and Behaviour

  • Excellent interpersonal skills
  • Able to express thoughts and ideas verbally
  • Excellent attention to detail
  • Ability to work both independently and as part of a team
  • Confident and intuitive
  • Desire to share good practice
  • Enjoys the challenge of problem solving
  • Able to acknowledge limitations and know when to seek advice

 

Qualifications

  • Degree or nursing level qualification, or equivalent relevant vocational experience
  • A Good Clinical Practice certificate is desirable

 

Newcastle University is committed to being a fully inclusive Global University which actively recruits, supports and retains staff from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from everybody, regardless of race, sex, ethnicity, religion, nationality, sexual orientation, age, disability, gender identity, marital status/civil partnership, pregnancy and maternity, as well as being open to flexible working practices.

 

Requisition ID: 1062