Clinical Trial Coordinator

Faculty of Humanities & Social Sciences

Newcastle University, Newcastle upon Tyne, UK

Overview

  • Posted on: 10th Aug 2021
  • REF: 10461
  • Closes: 01st January 1970
  • Contract Type: Fixed-Term/Contract
  • Hours: Full Time

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 starting from£30,942 to £32,817, with progression to £40,322 per annum

Closing Date: 17August 2021

The Role

We are looking for a highly motivated individual with proven ability in the coordination of clinical research, to cover maternity leave at the John Walton Muscular Dystrophy Research Centre, a multidisciplinary team working in translational research for neuromuscular diseases.

The purpose of this varied and challenging post is to manage a large portfolio of clinical research including national history studies and clinical trials. You will be expected to oversee all clinical research projects from protocol development to end of study, ensuring that all regulatory approvals are in place and that Good Clinical Practice is followed throughout a study.

Youshould have relevant experience of clinical trial coordination and the associated regulations and processes.An excellent communicator, with a proven ability to use initiative and plan workload effectively.

This maternity cover is a full time post available until 10th September 2022. Part time hours will be considered and this could be available to existing University colleagues as a Secondment. You should discuss this with your current manager before submitting your application.

Informal enquires toHeather.Hilsden@ncl.ac.uk

For further information please see:www.newcastle-muscle.org

Key Accountabilities

  • Early stage engagement with national and international sponsors and academic collaborators on study design, logistics and regulatory requirements.
  • Prepare and track submissions for Ethical, Health Research Authority and other relevant approvals including Site Specific Assessments, University/NHS Trust Research permissions and NIHR portfolio adoption.
  • Understanding NHS and University costing processes in order to coordinate complex costings for clinical trials and grant applications (and subsequent amendments), facilitating negotiations with funder representatives and ensuring that adequate funding is agreed.
  • Use of advanced communication skills over the life cycle of a study. Working with numerous internal and external stakeholders (nationally and internationally) simultaneously to ensure that:
    • Sponsor and academic collaborators are aware of local and national costing and regulatory requirements
    • Studies are opened in a timely manner
    • Recruitment targets are met
    • Relevant parties are aware of study progress
    • Clinical trial regulations are followed.
  • Preparation, submission and dissemination of study amendments, ensuring that changes are implemented in a timely and accurate manner.
  • Management of study systems and documentation in accordance with Good Clinical Practice (GCP) including master files, site files, databases, version control and document tracking.
  • Preparation for, facilitation of and action planning following audits and/or inspections from internal and external parties ensuring that study documentation is presented in accordance with GCP.
  • Take responsibility for continuous improvement of research administrative processes and target achievement, in line with changing regulations and faculty strategy
  • Take responsibility for identifying own learning needs and that of the research team, including identifying appropriate courses to ensure up to date knowledge in the regulations governing clinical research and research data
  • Undertake other reasonable duties or responsibilities as requested.

The Person (Essential)

Knowledge, Skills and Experience

  • Previous experience in relevant role
  • Knowledge of clinical research regulatory requirements in the UK
  • Knowledge of local and national research governance and management processes
  • National and international clinical trial experience
  • Experience of working to standards of Good Clinical Practice
  • An understanding of ethical issues surrounding research and patients
  • Knowledge of NIHR processes, including Portfolio adoption and expressions of interest/feasibility
  • Experience of assisting clinical trial recruitment, including recording and tracking of recruitment using LPMS and CPMS
  • Experience of preparing information for presentation and dissemination at meetings and scientific conferences

Attributes and Behaviour

  • Advanced oral and written communication skills
  • Ability to effectively prioritise workload, to use initiative and work under pressure, working independently as appropriate, but being aware when to refer decisions upwards or ask for further advice
  • Excellent attention to detail
  • High level of organisation
  • Occasional work outside core working hours will be required
  • Occasional international travel will be required
  • Proven track record in working as part of a multi-disciplinary team.

Qualifications

  • 1st degree in relevant subject or relevant experience working in clinical research
  • Formal training in GCP

Newcastle University is committed to being a fully inclusive Global University which actively recruits, supports and retains colleagues 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.

The University holds a silver Athena SWAN award in recognition of our good employment practices for the advancement of gender equality. The University also holds the HR Excellence in Research award for our work to support the career development of our researchers, and is a member of the Euraxess initiative supporting researchers in Europe.

We understand how important the full employment package is to our colleagues at Newcastle University and we are committed to providing a great range of benefits and discounts for all. You can learn more about what is available here on ourBenefitsWebsite page.

Requisition ID: 10461

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