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Clinical Trials Coordinator

2 months ago

Birmingham, Birmingham, United Kingdom University Hospitals Birmingham NHS Foundation Trust Full time
Job Summary

We are seeking a highly motivated and organized Clinical Trials Coordinator to join our Core Research team. As a key member of our team, you will be responsible for managing a portfolio of clinical trials, ensuring compliance with research governance and ICH GCP regulations.

About the Role

The successful candidate will have significant relevant experience in clinical trial/research data management, with a strong understanding of current legislation regarding research governance issues. You will be responsible for maintaining and updating the Trust Research Database, accessing the Trust's IT systems to retrieve and analyze relevant information, and supplying data to the Network Research Manager regarding progress of clinical trials.

Key Responsibilities
  • Contribute to the management of the local portfolio of clinical trials
  • Maintain and update the Trust Research Database
  • Access the Trust's IT systems as required to retrieve and analyze relevant information
  • Supply data as required to the Network Research Manager regarding progress of clinical trials
  • Ensure that trial-specific investigations are undertaken as required by the research protocol in order to establish eligibility to enter the trial
  • Randomize/register patients to trials according to protocol requirements
  • Assist in ensuring that protocol-required tests/procedures are done according to the schedule in the specific protocol
  • Collection of patient data from medical notes and completion of case record forms (CRFs) and liaise with Clinical Trial Officers, Research Nurses, and Clinicians to ensure correct data collection
  • Transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the protocol
  • Ensure safe filing and storage of study documentation and samples in accordance with ICH GCP and Research Governance
About Us

University Hospitals Birmingham NHS Foundation Trust is recognized as one of the leading NHS Foundation Trusts in the UK. Our vision is to Build Healthier Lives, and we recognize that we need incredible staff to do this. We are committed to creating the best place for our staff to work, offering flexible working, a wide variety of training and development opportunities, and a kind and inclusive environment that empowers staff to challenge discriminatory behaviors and bring their whole self to work.

Person Specification

Essential

  • O' Levels/GCSEs specifically English and maths at grade C or above
  • 'A Levels'
  • Education to degree level or diploma level plus relevant experience to degree level
  • Significant relevant experience in clinical trial/research data management
  • Experience of research in a healthcare setting
  • Understanding of current legislation regarding research governance issues

Desirable

  • Previous experience of line managing staff, completing PDRs, and a basic understanding of the HR requirements of managing sickness, maternity, disciplinary action, etc.
  • Knowledge of National policies, procedures, and initiatives or current issues facing the NHS
  • Knowledge of ICH GCP

Additional Criteria

  • Evidence of punctuality
  • Evidence of being able to adapt working hours to a deadline
  • Evidence of being a team player