Job ProfileJob Description

Job Details

Job Title: Clinical Trial Practitioner

School/Dept/Institute & Centre: William Harvey Research Institute

Reports to: Laura White, Clinical Trials Manager

Grade: 3 Full Time (£26,717 - £32,956)

Appointment period: 24 months

Current Location: Primarily based at Mile End Hospital, although the post-holder may be required to move to another of the School’s sites should the need arise.

Job ContextTo provide professional clinical and administrative support to the Rheumatology team at the Bart’s Arthritis Centre, Mile End Hospital to ensure the smooth running of clinical trials.

Job PurposeWork as part of the Rheumatology clinical trial delivery team, being mutually supportive and covering duties as necessary during colleague’s absences and at times additional pressure, as directed.

Main Duties & ResponsibilitiesResearch and Clinical Duties:

• Responsible for maintenance of patient recruitment records and day-to-day management / organisation of clinical trials and studies, to include: data collection and database management, preparation and storage of clinical samples, and compliance• Create and maintain Investigator Site Files• Maintain up-to-date knowledge of research legislation and governance issues• Identify patients suitable for entry into clinical trials and principal investigators to review and recruit.• Ensure study protocols and procedures are adhered to in accordance with local practice and Good Clinical Practice Guidelines• Support patients throughout the delivery of their care on clinical trials, seeking appropriate assistance to ensure that their concerns are addressed• Organise patient assessments and visits as appropriate to relevant study protocols.• Coordinate collection and preparation of biological samples as per protocol• Keep up to date with cannulation and phlebotomy training/certification, as well as other Rheumatology specific assessments (e.g. joint assessment)• 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

Other Duties:• In addition, the post holder will be expected to carry out any other duties and responsibilities within the scope, spirit and purpose of the post and its grading as requested by the line manager. These will include sharing in departmental duties. Note: This job description reflects the present requirements of the post. As duties and responsibilities change and develop the job description will be reviewed and be subject to amendment in consultation with the post holder.

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Job ProfileJob Description

• Ensure that all research is undertaken according to GCP, Trust and College protocols• The post holder must at all times carry out their responsibilities with due regard to the College’s Equal Opportunities policy.• Receive, and respond to, everyday enquiries from/to the Rheumatology Team, Research Nurses and Clinical Leads/Investigators, escalating requests outside one’s knowledge base to the appropriate person/area, to provide a timely and effective service to others in the provision of standard information• Administrative and/or support activities related to the duties listed above and those required to contribute to the smooth operation of the Bart’s Arthritis Centre studies portfolio.• Keep up to date with current guidelines (e.g. Good Clinical Practice) related to clinical trials coordination and administration.• To ensure that all research is undertaken according to Good Clinical Practice (GCP), College and Trust protocols.• To ensure that they are fully aware of and comply with the College’s/Trust’s policies and procedures in relation to confidentiality, health and safety at work, and all local safety rules regarding fire, chemical, radioisotope and gene manipulation hazards.• To assist with the development and production of reports, guidelines, educational material, grant applications.• To use forward planning and goal setting to assure that projects proceed to target.• Post holder will be required to make decisions:

• Concerning informed consent, making of appointments and process of follow-up.• About data in medical records.

• To ensure patient care is conducted in accordance with GCP• To adopt flexible working practices where required.• Prioritise own workload to ensure deadlines are met using skill and judgement with reference to clinical trial priorities, using problem solving skills to identify and implement solutions; deciding on appropriate course of action; communicating effectively with colleagues; seeking guidance from other staff as required.• To be aware of own limitations and refer problems relating to studies to their line manager as appropriate.• To work as part of a multidisciplinary team of clinicians, scientists, nurses and support staff, developing good working relationships within the team, and making use of discussions with the project supervisor(s), and other team members as appropriate, to establish and maintain excellent communication links.• Provide progress reports to the Senior Management Team regarding study activities both verbally and written.

The above list of responsibilities is not exhaustive and the jobholder may be required to undertake other duties commensurate with the level of the role, as reasonably requested by their line manager.

This job description sets out the duties of the post at the time it was drawn up. Such duties may vary from time to time without changing the general character of the duties or level of the responsibility entailed. Such variations are a common occurrence and cannot in themselves justify a reconsideration of the grading of the post.

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Job ProfilePerson Specification

This table lists the essential and desirable requirements needed in order to perform the job effectively. Candidates will be shortlisted based on the extent to which they meet these requirements.

Requirements Essential / Desirable

How Assessed

Qualifications Mathematics & English – GCSE equivalent Grade A-C E A

A Levels or equivalent Grade A-C. (including a science) E A

Degree in biological sciences D A/I

Knowledge,Skills andExperience

Experience of working in a clinical research environment E A/I

Experience of working in a healthcare setting, i.e. speaking to patients and/or public D A/I

Experience of clinical trial data entry E A/I

Knowledge, Evidence of awareness of Good Clinical Practice and the regulatory environment that surrounds clinical research E A/I

Skills & Experience of working as part of a multidisciplinary team E A/I

ExperienceDemonstrable IT skills, including: e-mail, word processing and databases (Microsoft Office packages, other database programmes)

E A/I

Knowledge of local and national clinical trial regulations D A/I

Effective communication in written and verbal English E A/I

Must demonstrate critical and intelligent attention to detail and high standards of accuracy E A/I

Demonstrates a commitment to further learning and professional development E A/I

Knowledge and understanding of medical terminology E A/I

Previous use of Trials Research Management Software D A/I

Demonstrable evidence of phlebotomy training/certification D A/I

Professional disposition E A/I

Ability to work on own initiative and problem solve to organise and manage the work of a professional team under management guidance

E A/I

Flexible and co-operative E A/I

Willingness to travel as required (within the UK) to participating sites as required to complete duties above E A/I

Willingness to work on different QMUL sites E A/I

Essential/Desirable: E = Essential: Requirements without which the job could not be done.D = Desirable: Requirements that would enable the candidate to perform the job well.

How Assessed:A = Application I = Interview OM = Other Means (e.g. presentation, test, etc.)

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