Clinical Trial Administrator

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The Clinical Trial Administrator (CTA) supports the efficient management of clinical trials, work closely alongside Research Nurses and other members of the clinical team to ensure complete, accurate and timely reporting of clinical trial data is submitted to trial co-ordinating centres. Working closely with the senior team, the CTA helps maintain an up-to-date portfolio of clinical trials and contributes to the review and implementation of Standard Operating Procedures (SOPs).

The CTA is responsible for proposing improvements to working practices, maintaining stock control for clinical trials, and performing general administrative duties to support the clinical research team. This includes managing trial documentation, ensuring accurate data entry, and coordinating patient follow-up appointments and investigations. The role requires strong communication skills to liaise with patients, clinical staff, and sponsors.

Key responsibilities also include assisting in the preparation of reports, activity summaries, and communication materials, managing sensitive data, ensuring compliance with regulatory guidelines. The CTA will assist in audits, monitor non-commercial studies, and help with reception duties as required.

The position requires a high degree of organisational skills, attention to detail, and the ability to manage multiple tasks simultaneously. The CTA is expected to stay updated with relevant IT skills and governance, contribute to training programs, and maintain adherence to policies and regulations related to data protection and health and safety.

DUTIES AND RESPONSIBILITIES

1.    To ensure that systems for data collection and project management of trials and their amendments are maintained.

2.    Together with Senior Clinical Trial Coordinator contribute towards the maintenance of an up-to-date portfolio of clinical trials.

3.    Contribute to the review and implementation of Standard Operating Procedures. Propose changes to the Senior Clinical Trial Administrator to improve working practices.

4.    Make agreed changes to own work within agreed timescales.

5.    Make constructive suggestions to working practices as to how the service can be improved for users and the public.

6.    Responsible for maintaining and managing stock control for clinical trials and request/re-order when necessary.

7.    To undertake general administrative duties and maintain electronic and paper filing systems as required in support of the team.

8.    To assist with the acquisition and distribution of trial documentation and to establish and maintain a site file for each trial when required.

9.    To ensure all relevant information is available to enable clinical staff to assess patient eligibility against a trial protocol.

10. To ensure relevant data is recorded in accordance with the requirements of the trial Protocol.

11. To assist the Research Nurses in arranging follow up appointments and investigations for patients.

12. To retrieve investigation results for review by the clinical team as required.

13. To communicate effectively with patients and all disciplines of staff involved in each research study.

14. To provide administration support to the Research Nurses and wider research team within the Trust.

15. To provide and respond promptly to requests for routine information, which can be complex and sensitive, to support the local and national reporting obligations of the Trust and the Regional Research Delivery Network (RRDN), as required.

16. To meet regularly with the Senior Clinical Trial Administrator to ensure all required parties are aware of the status of ongoing tasks.

17. To contribute to communication materials including activity reports, presentations, posters and newsletters for distribution throughout the Trust and RRDN, as required.

18. Ensure good working relationships with the research teams caring for patients participating in research.

19. To provide non-clinical advice, information and guidance to patients, public and clinical trial sponsors.

20. To assist research patients and relatives when they are attending the Clinical Research Centre.

21. To communicate with sponsors and dealing with any issues or complaints and escalating where necessary.

22. To report all accidents, incidents and near misses as per Trust Policy.

23. Support others to manage risks effectively.

24. To support the delivery of designated research projects in accordance with Good Clinical Practice (GCP), the UK Policy Framework for Health and Social Care Research, applicable regulations, and local Trust policies, procedures and standard operating procedures (SOPs), escalating any issues or concerns to the Senior Clinical Trial Coordinator.

25. Manage, organise, prioritise and adjust own workload in a manner that maintains and promotes quality and is in line with required trial deadlines. Work will be assessed with the Senior Clinical trials at agreed intervals.

26. Contribute to the standardisation of data management support and share good practice.

27. Plan and organise activities required within a clinical trial e.g. clinical trial monitor visit. This includes several activities which are ongoing at the same time.

28. Responsible for data entry onto numerous computer-based systems.

29. Ensuring safe storage of sensitive data.

30. Follow guidance from policies, SOPs and trial protocols to ensure work is of a high standard.

31. Results/outcomes of work will be assessed at agreed intervals by the clinical trials sponsor and the Senior Clinical Trials administrator.

Personal

1.    Actively participate in appraisal and a yearly performance review.

2.    Maintain a Personal Development Portfolio, in line with the Trust policy.

3.    Identify own professional development needs to the Senior Clinical Trial   Administrator.

4.    Keep up to date with developments in relation to own role.

5.    To attend lectures, conferences and seminars as appropriate to role.

6.    Alert the Senior Clinical Trial Administrator of any resource issues which affect delivery of the service or performance.

7.    To keep up to date with relevant IT skills and governance relating to this post.

8.    To contribute to the training, induction programme and orientation for new members of the research team, providing demonstrations of work activities and help/advise.

9.    To contribute to the department's annual training day delivering administrative training.

10. Undertake departmental and trust induction and mandatory training.

11. Undertake any study specific training and gain an understanding of how each individual external sponsor and clinical trial work.

12. Undertake structured departmental and research specific training, this includes a study programme and on-the-job training.

13. Occasional problem-solving skills required, e.g. patient follow ups and sample collection. You must determine the best course of action if there is a problem or issue to resolve the problem.

14. To be fully aware of and committed to all Policies, Procedures and Initiatives relating to Information Governance - this will include, but not limited to, Data Quality Improvements, Confidentiality and Information Security

15. To always ensure compliance with the Data Protection Act, GDPR and Good Clinical Practice.

16. Conform to health safety and security legislation, policies, procedures and guidelines.

17. Responsible for safe use of equipment.

18. To follow health and safety training when frequently using notes trolley and/or transporting files or equipment.

19. To comply and follow Standard Operating Procedures and policies.

20. Requirement for keyboard skills

General

1.    All ad-hoc administrative duties in relation to research projects.

2.    To assist in the planning and preparation with the audit and monitoring of non-commercial studies.

3.    Receive incoming telephone calls to the RM&G Office including resolving routine enquiries, taking messages or directing calls elsewhere as necessary.

4.    Covering reception desk in the absence of the Research and Development Receptionist.