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My Client requires a Clinical Studies Officer/Research Nurse to help facilitate the establishment of a broad clinical trials portfolio. This would involve running study feasibilities, contacting and recruiting patients into trials and leading a small team of data managers also engaged in these tasks. The post holder would also be required to assist on trial delivery and supporting staff members.
The function of the Clinical Trial Officer/ Research Nurse is to assist in the provision of clinical trials with a particular emphasis on Industry Trials. The postholder will engage with clinicians working across multiple care pathways to help identify patients for studies, run enhanced feasibility and help maintain research registers at the Trust which aid Recruitment and Feasibility.
The postholder will work collaboratively with the clinical trials team.
The role involves using an in depth knowledge of trial protocols and their application in practice, along side a working knowledge and compliance with the local, national and international research regulations.
DUTIES AND RESPONSIBILITIES
1.Maintain effective communication with patients, carers and professionals to ensure service delivery.
2.Attend multidisciplinary meetings and appropriate clinics, to screen and recruit new patients, and to operate as a research resource to members of the Clinical Trials Facility.
3.Ensure that trial specific investigations are undertaken as required by the trial protocol, in order to establish eligibility and safety to enter the trial.
4.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.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.Maintain accurate patient records and ensure all relevant information is documented in the patients' medical and nursing notes.
7.Responsible for accurate and timely completion of case 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 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 co-coordinator/PI and relevant local personnel/regulatory authorities.
11.Act as a primary contact point for the clinical trial patient providing ongoing follow-up care whilst the patient is in the clinical trial.
1.Assist in the review of trial protocols and identify resource implications for the site. Liaise with and seek specialist input as appropriate i.e. Clinicians/ treatment units / specialist nurses/pharmacy/radiology/pathology.
2.Identify strategies for recruiting patients to clinical trials.
3.Ensure that the portfolio of clinical trial protocols is adhered to.
4.Ensure that you and the team are working according to GCP and research governance standards for clinical trials. Facilitate the informed consent process ensuring the following is accounted for: -
a.The patient (and significant others) fully understands the nature of the clinical trial.
b.The patient is aware that entry into the trial is voluntary and they can withdraw at any point without prejudice.
c.The patient is aware of any extra procedures required by the trial
d.The consent form is completed accurately and filed as required.
5.Responsible for forwarding trial data in a timely manner to the trial co-ordinating centre.
6.Liaise with clinical trial personnel outside the hospital as necessary.
7.Supply data as required regarding progress of clinical trials.
8.Register/randomise patients into trials.
9.Identify barriers to recruitment to trials and ensure that the Senior Trial Coordinator is aware of them. Identify and implement/support action plans as required.
10.Provide support for clinical trial colleagues in their absence.
11.Attend meetings relevant to the nature of the job.
Management and Administration
1.Assist in the process of gaining local regulatory committee approval (Ethics and R&D approval).
2.Contribute to the development of clinical and research policies/procedures/Standard Operating Procedures (SOP's)
3.Ensure that clinical trial recruitment records are accurately maintained.
4.Maintain study site files and documentation.
5.Liaise with the members of the multi - disciplinary team i.e. Pharmacists, Radiologists, and Pathologists to establish procedures for the safe and smooth running of clinical trials.
6.Access the computer network as required retrieving relevant information.
7.Ensure that clinical trials are effectively archived as required.
8.Provide information to allow for invoices relating to trials to be raised for payments where appropriate
Education and Training
1.Act as a resource for colleagues in relation to clinical trials.
2.Ensure that all relevant health care professionals are educated and supported as required enabling them to care for clinical trial patients.
3.Keep all-appropriate staff informed of the progress of clinical trials.
4.Continue your own professional development, keeping updated with current practice.
5.Maintain links with other, research personnel and Clinical Nurse Specialists across the organisation to share knowledge and to provide mutual support.
6.Attend meetings in relation to clinical trials as appropriate and agreed with the R&D Director
7.Provide regular teaching across the Trust on the subject of clinical trials to promote clinical trial awareness.
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