Clinical Research Officer

Job responsibilities

Clinical

• To coordinate the care of your own caseload of clinical trial participants
• To attend Multi-disciplinary Meetings, and appropriate clinics, to screen and recruit new participants, and to act as a resource to the members of the MDT.
• To ensure the safe administration of treatments and medications, given within the context of a clinical trial and within the scope of relevant professional practice.
• To ensure that trial specific investigations are undertaken as required by the trial protocol, in order to establish eligibility and safety to enter the trial.
• To provide ongoing information, education and support to children, carers and families regarding clinical studies.
• To ensure blood and other samples are collected for pharmacokinetic studies as required by the trial protocol.
• To monitor treatment toxicity/side effects and initiates changes to treatment as required by the protocol within the scope of relevant professional practice.
• To maintain accurate documentation of research related activities in Study, Nursing and Medical notes.
• To accurately record data collected in the Case Report Forms (CRF).
• To record and report adverse events to the relevant personnel and take any necessary action.
• To report and record serious adverse events to the Trial Co-coordinator/Principal Investigator (PI) and relevant local personnel / Regulatory Authorities.
• To provide ongoing follow up care whilst a subject is in a clinical study.
• To act as a primary contact point for patients/subjects in a clinical study.
• To follow appropriate Trust Policies and Procedures and to ensure that you are working according to Good Clinical Practice and Research Governance standards for clinical studies

Clinical Research

• Responsible for assessment of research care needs, the planning, implementation and evaluation of care delivered, so that patients individual requirements for research care are met.
• Carry out policies and procedures in accordance with agreed Trust policies and standards.
• Be aware of and adhere to Trust policy for Administration of Medicines where relevant to professional boundaries.
• Demonstrate initiative and competence in all clinical procedures undertaken independently and when assisting medical staff.
• Ensure that the processing and storage of biological samples meets the necessary requirements of the research protocol in order to make certain that safe handling and quality is assured.
• Adhere to COSHH, Health and Safety, infection control and relevant Trust policies and procedures, actively supporting all staff to comply with these requirements.

Communication

• Facilitate and maintain effective communication and education within the multidisciplinary team, in order to promote efficient clinical research.
• Maintain accurate patient records in accordance with the trust policy on record keeping and in accordance with Good Clinical Practice (GCP) and International Conference of Harmonisation (ICH) guidelines
• Develop and utilise IT skills e.g. keyboard, word processing and database skills, adapting to the required needs of specialist trial specific systems
• Communicate with and provide support for clinical research patients relatives, carers and visitors.
• Be aware of the need for confidentiality both with the written and spoken word and ensure correct storage of patient and research records at all times.
• Liaise with wards and departments as necessary for the co-ordination of patient research care and the smooth running of the research visit.

Education and Training

• as a resource for colleagues in relation to clinical studies.
• To educate and support health care professionals in the clinical teams, to enable them to care for children in clinical studies.
• To keep appropriate staff informed of the progress of clinical studies.
• To maintain an up-to-date knowledge of paediatric research related articles particularly related to clinical studies.
• To continue your own professional development according to appropriate regulatory guidance, keeping updated with current practice.
• To maintain links with other clinical trial staff and professionals to develop and share knowledge and to provide mutual support.
• To attend local, regional and national meetings in relation to clinical studies as appropriate and agreed with local training link.
• To maintain an awareness of current advances in paediatric treatments, research and clinical practice and use this knowledge to maintain the highest standard of care for children.

Managerial

• Support and co-operate with all members of department staff to ensure efficient running of the research.
• Make optimum use of resources in order to provide quality research within the budget. Utilise all resources efficiently and effectively, maintaining stock levels of trial equipment and supplies ensuring equipment is available and in safe working order.
• Report all accidents and untoward incidents as per Trust policy and research processes.
• Help develop induction packages and ensure new staff are adequately prepared to function safely within the clinical research environments.
• Comply with Health and Safety and Infection Control policies and ensure that staff, patients and visitors are aware of the procedures. Maintain a safe and healthy working environment.
• Develop leadership skills e.g. effective time management, a positive approach to challenges, flexibility and adaptability in the face of a continuously changing environment.
• Need to be aware of the principles of risk management and clinical governance in relation to research and the ward/department/unit.

Professional

• Attend courses, meetings and conferences as necessary. Undertake mandatory training according to Trust and local policies.
• Always act with regard for the privacy and dignity of the patient.
• Maintain personal and professional development in line with statutory requirements as well as knowledge and skills appropriate to the area of work. Keep up to date with current and potential research information relevant to the care of patients/volunteers in the clinical area.
• Participate in the research competency document / Individual Performance Review process.
• Undertake any other duties which may be reasonably required, in addition to those attached relating to your specific area.
• Actively develop and participate in educational programmes in the department. Contribute towards maintaining an environment conducive to learning and the development of research.
• Exercise professional accountability at all times and to be aware of own development needs/limitations, actively seeking to address these.

Speciality Specific

• Provide research advice to other clinical areas, as necessary, in order to facilitate the management of patients with special research requirements for care.
• Safeguard the interests of patients/volunteers by liaison with relevant study personnel, contributing to study design and protocols, ensuring compliance with ICH-GCP guidelines, the EU Clinical Trials Directive and in accordance with the Research Governance Framework (DoH 2001).
• Provide ongoing advice and information to patients with regard to their participation in clinical research in order to facilitate effective informed consent.
• Help recruit patients into clinical trials by carrying out screening observations, helping to obtain written informed consent when required and help check eligibility criteria is met.
• Facilitate a participants withdrawal from a study where necessary, in order to ensure the effective achievement of the study aims and/or to protect the participants welfare.
• Ensure accurate collection of data and assist with the completion of case report forms, providing source document verification.
• Assist with reporting serious research adverse events in accordance with protocol.
• Obtain pharmacokinetic blood samples, process and store plasma samples in accordance with relevant trial protocol.
• Help liaise with clinical and non-clinical support departments to ensure all requirements of an individual study have been negotiated and approved during the development of the research protocol, and are in place for its implementation.
• Inform and update G.Ps on their patients participation in clinical studies.
• Ensure that all ICH-GCP required documentation is kept in a clearly traceable system and is stored for the appropriate length of time.
• Identify the training and education implications of each protocol and develop appropriate strategies to meet these in order to ensure the safe and accurate implementation of the study by self and others.
• Perform other clinical trial procedures competently and in accordance with local Trust policies and study related protocols e.g. ECG, pregnancy testing, venepuncture.
• Contribute towards ensuring that research influences clinical practice.
• Assist senior staff in the development of protocols and Standard Operational Procedures for research practice and ensure these are reviewed and updated on a regular basis.
• Participate in clinical study monitoring both internally and externally in order to meet the governance requirements of each study.
• Ensure that the rights, dignity and confidentiality of the patient/volunteer are protected at all times.

Qualifications

Essential

• Educated to degree level or equivalent experience
• Good Clinical Practice trained (GCP)
• A good level of IT skills demonstrated by competence in Microsoft software packages i.e. outlook, word processing, database and spreadsheets
• Required to participate in ongoing Professional and Personal Development and undertake additional training as required

Desirable

• Evidence of appropriate further education/development
• Research qualification
• IT Qualification e.g. ECDL
• Knowledge of research governance and regulations (e.g. ICH-GCP and EU Directives)
• Knowledge of research methodologies

Experience

Essential

• Knowledge and experience of supporting complex clinical trials
• Experience in a NHS setting that involves patient/customer care
• Sample preparation and handling.
• Data entry experience
• Experience of independently working with minimal supervision.
• Able to manage a caseload of clinical trials with some autonomy and confidence.
• Experience of Microsoft Access and Excel

Desirable

• Experience of working in a paediatric setting

Communication and relationship skills

Essential

• Excellent verbal and written communication skills.
• Able to communicate effectively at all levels.
• Able to provide and receive information orally, in writing or electronically in order to undertake own job and inform work colleagues, patients, carers external bodies and various hospital departments.
• Able to display empathy, tact, reassurance and diplomacy when receiving and providing information. (This is occasionally complex and sensitive confidential information).
• Ability and experience of working as part of a team.
• Clear understanding of the importance of confidentiality

Analytical and judgement skjills

Essential

• Able to interpret clinical/non-clinical data and events in order to input accurate information.
• Prioritise/reprioritise own workload to coordinate with deadlines as determined by others

Planning and organisation skills

Essential

• Excellent organisational skills.
• Good time management skills in order to organise and prioritise own short term and long term workload.
• Able to use own initiative
• Able to pay attention to detail and accurately complete case report forms etc.
• Able to change tasks according to changing priorities.
• Able to stay calm under pressure

Physical skills

Essential

• Able to use a keyboard and accurately prepare paperwork.
• Able to support patient transfer between departments.
• Able to transfer study equipment between departments
• Able to use a computer for large periods of time in a busy office with other staff

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).