Clinical Research Practitioner

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CLINICAL AND RESEARCH:

With assistance implement and facilitate the running of research studies and trials within the airways team, working within agreed scope of practice.

Clinical

• Plan and coordinate your day-to-day work in collaboration with the senior research nurse

• Manage a caseload of people who have consented to participate in certain studies.

• Undertake study procedures required and in line with the research protocol.

• Keep up to date with cannulation and phlebotomy training/certification, as well as other specific assessments (ECG, vital signs, spirometry)

• Participate in registration/randomisation of patients on to study protocols, ensuring that all pre-study tests have been undertaken and results obtained.

• Delegate and refer to other research team members when risks and needs are beyond own competence and scope of practice

•  Ensure effective communications between trial centres, sponsors and investigator sites nationally and internationally.

• Perform manual data validation checks for inconsistencies and unclear or missing data prior to data entry and raise, track and resolve data queries 

• Take part in reflection and appropriate learning from practice, in order to maintain and develop competence and performance

• Provide accurate and timely information, education and support to patients (and their significant others) regarding clinical research.

• Maintain accurate documentation.

• Have an understanding of adverse event reporting and recording, and ensure that the team, Principal Investigator and Study co-ordinator are made aware of any such events.

• Act at all times in a way that maintains patients’ and carers’ dignity.

• Refer to other specialists as required in order to provide optimal patient care.

• Participate and provide care to NHS clinics as required

Research

• Work according to GCP and research governance standards for all aspects of work practice.

• Coordinate non-complex studies under the supervision and support of senior colleagues.

• Adhere to clinical study protocols and report protocol deviations and violations to study coordinator.

• Have an awareness of legislation and the Mental Capacity Act; take informed consent as per study protocols.

• Register/randomise patients into studies.

• Assist in the identification of patients eligible to enter clinical studies.

• Ensure that clinical trial records are accurately maintained.

• Ensure that own case report forms are accurately completed, in paper and electronic format.

• Communicate effectively with the rest of the study team and patients/carers.

• Keep up to date with departmental, Trust, NHS, and EU developments for the management of clinical research.

• Provide support for clinical trial colleagues in their absence.

Administration

• Use the Trust and University computer systems/network and the internet.

• Ensure that all data is handled according to the Data Protection Act and in a confidential, and where necessary anonymised, fashion.

• Support the Research Team/Study Co-ordinator in the event of inspection from a regulatory and/or monitoring authority.

• Attend meetings relevant to the nature of the job.

• Input to recruitment strategies. Support and assist in the development of action plans as required.

Education and Training

• Promote research across the network in relation to clinical trials.

• Assist in the education and support of clinicians and service users.

• Continue your own personal and professional development keeping updated with current practice.

• Contribute to performance development review processes.

• Proactively seek opportunities for personal development and progression.

• Attend national meetings and training as relevant to role.

GENERAL REQUIREMENTS

• Project a professional and positive image of the Oxford Airways team.

• Keep up to date with all new developments within the department and develop own skills and competencies.

• Participate in an individual personal development review.

• Ensure that annual leave is appropriately authorised, and sickness absence is reported in line with Trust policy.

• Travel as required across Thames Valley and South Midland Clinical Research Network and Nationally.