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PRIMARY DUTIES & AREAS OF RESPONSIBILITY

Leadership

1. Have an understanding of the clinical research team work-plan and contribute to its achievement.

2. Manage research performance and study timelines of relevant studies.

3. Collaborate with other Trusts and organisations within the region to improve research delivery.

4. Keep up to date with research management issues through liaison with other Research Specialists /Team leaders and link with national networks.

5. Provide relevant supervision and mentorship to members of staff and students.

6. Take responsibility for own health, safety and security and promote the health, safety and security of the wider team.

7. Contribute to the development and implementation of clinical and research policies, procedures and SOPs.

8. Facilitate and maintain effective communication within the research team and between the multidisciplinary clinical team.

9. Assist in the delivery of education and training regarding research for the wider Multidisciplinary Team and act as an ambassador for research.

10. Promote a blame free culture in reporting incidents and where appropriate support local investigation of incidents.

11. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate.

 Research

1. Be responsible for the delivery of a clinical trial portfolio relevant to the specialty.

2. Ensure that the delivery of studies meet requirements with regards to the Department of Health’s Research Governance Framework for Health & Social Care and the EU Clinical Trials Directive by implementing quality systems.

3. Participate in Good Clinical Practice (GCP) training.

4. Contribute to the Expression of Interest / Study Selection process for the relevant specialty.

5. Contribute to study set up, recruitment planning and study delivery.

6. Lead forward and contribute to Patient and Public involvement activities.

7. Be responsible for promoting the appropriate referral and recruitment of patients to clinical research studies. Work with the clinical trials team and investigators to develop strategies to overcome barriers to recruitment and to solve other problems relating to specific studies.

8. Coordinate and run study visits including off site visits whilst adhering to the lone worker policy.

9. Work with other departments within the Trust to ensure that trial specific investigations and procedures are undertaken as required by the trial protocol, in order to establish eligibility and safety of patients within clinical trials.

10. Contribute to the accurate costing for clinical trials

11. Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act.

12. Ensure that data is transcribed accurately where required and assist with the maintenance of the Trial Master File.

13. Respond to data queries generated by the study coordinating team within a timely manner.

14. Ensure the recording & reporting of adverse and serious adverse events that occur whilst the participant is in the clinical trial to the trial co-coordinator/Principal Investigator (PI) and R&D office in line with the study protocol, local policies and regulatory requirements.

15. Assess and evaluate the progress of on-going clinical trials for which the post holder has responsibility, maintaining accurate records of the status of studies and providing regular updates to the department on the status of the studies. This will involve ensuring that any Data Management Systems are updated with key trial data and validated efficiently.

16. Escalate on-going study performance issues to the Senior Research Nurse or Team Lead.

17. Co-operate with external and internal audit, data monitoring and quality assurance by working with R&D, sponsors, study monitors and external bodies.

18. Assist in study close down and the preparation of results of research for presentation as posters, abstracts, papers or scientific presentations.

For further details please see attached JD&PS.