She will be member of the North East Stroke Research Network (NESRN) team and will be responsible for co-ordinating a portfolio of stroke clinical trials. As a Clinical Trials manager she will be responsible for the recruitment, education and monitoring of trial patients and the collection and documentation of accurate data. She will also be responsible for the complete co-ordination of trials, including submission of trials Trust R&D approval. She will liaise with Trust management where appropriate.
Clinical Professional and/or Technical Responsibilities
1. To work autonomously to manage his/her caseload of patients whilst working as part of a Multi-Disciplinary Team (MDT). Maintain effective communication with patients, carers and professionals to ensure service delivery.
2. To attend MDT meetings, and appropriate clinics, and to operate as a research resource to the members of the MDT.
3. To ensure that the trial specific investigations are undertaken as required by the trial protocol, in order to establish eligibility and safety to enter the trial.
4. To act as a resource and support to patients and their significant others, explaining practical aspects of clinical trials. Work with clinical teams to map the patient pathway for each trial.
5. To arrange collection of blood samples required as part of the clinical trial and ensure safe and appropriate storage of specimens in conjunction with local nursing teams/phlebotomy/laboratory staff.
6. To maintain adequate patient records and ensure all relevant information is accurately documented in the patients' medical and nursing notes.
7. To be responsible for accurate and timely completion of Clinical Report Forms (CRFs).
8. Monitor treatment toxicity/side effects and ensure changes to treatment as required by the protocol.
9. Record and report adverse events that occur whilst the patient is in the clinical trial in a timely manner to the relevant personnel and act as required.
10. Report and record serious adverse events that occur whilst the patient is in the clinical trial to the trial co-ordinator/PI and relevant local personnel/regulatory authorities within agreed timescales.
11. To provide ongoing follow-up care whilst the patient is in the clinical trial.
12. To maintain an up-to-date knowledge of stroke research related articles particularly related to clinical trials.
13. Continue your own professional development, keeping updated with current practice.
14. Maintain awareness of current advances in stroke treatments and research practice.
1. Act as a resource for colleagues in relation to clinical trials.
2. To ensure that all relevant health care professionals are educated and supported as required enabling them to care for clinical trial patients.
3. To keep all appropriate staff informed of the progress of clinical trials.
4. To maintain links with other Clinical Trial Officers, research personnel and Clinical Nurse Specialists across the network to share knowledge and to provide mutual support.
5. Attend national meetings in relation to clinical trials as appropriate and agreed with local training link and Research Network Manager.
6. Assist in the preparation of posters for meetings and conferences. Also circulate trial information and carry out presentations to promote trial activity locally.
7. To provide regular teaching across the Trust on the subject of clinical trials to promote clinical trial awareness.