Clinical Research Practitioner / Physiotherapist, STEPS II project

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Patient/Client Care Work in partnership with the Chief Investigator and clinical teams to conduct the STEPS II project. This post will NOT support the activities listed in the AcoRD guidance as NHS treatment costs. Provide specialist information and advice to study participants in relation to the STEPS II Project. Work autonomously and provide information and leadership in relation to the research being in undertaken Responsibility for Information Resources Responsible for all paper based and computerised trial data entry (compiled by the post holder and/or other members of the research team) for use within the Trust and by external partners Responsible for ensuring that all trial data is stored in accordance with the data protection act (1998) Ensure the accuracy, completeness, legibility and timeliness of data recorded in all study related reports Keep clear, concise records (in terms of patient documentation and data collection) that are accurate, complete, legible and timely, in accordance with the regulatory requirements and the protocol requirements.

This will include sending data in the required format to study organisers in accordance with the data protection act (1998) and ensuring that data collected can be verified at source and is kept in a way that complies with legislation. Participate in research meetings and ensure accurate information is fed to the study organisers and clinical teams. Use computer software to create research reports upon request Ensure data is available to consultants, researchers and sponsor for audit, quality assurance and analysis Regard effective communication as a key to successful care delivery. Financial and Physical Resources responsible for the management of the day to day needs of studies ensuring that materials/stock required are available, in date and used safely and correctly.

Handle petty cash; Manage the small budget for the non-staff costs associated with this post liaise with the CI to identify resource implications ensure that the financial arrangements are adhered to and that information is provided as required raise invoices in accordance with the study agreement as appropriate Human Resources Responsible for communication of research related information throughout the team and for working with colleagues to meet the needs of the research protocols and care for patients throughout their time in the study. They may in the future as the service develops be required to take on line management responsibility for a research practitioner or trial administrator Respond to learning needs of other staff and co-ordinate the relevant training of research staff in relation to the study protocols Analytical and Judgmental Skills The post holder, in partnership with the Principal Investigators and clinical team, will be caring for people with clinical Conditions whilst they take part in clinical research, this will include using clinical judgement regarding a range of clinical issues or complex patient conditions e.g. when assessing side effects, or selecting and recruit participants according to trial specific inclusion / exclusion criteria. Physical Skills Ability to use clinical equipment or physical skills to assess study participants in accordance with the study protocol Ability to undertake pertinent clinical skills as required.

KEY TASKS Research activities are a central part of work activity. 100% of time is dedicated to the STEPS II Project Work with the Chief Investigator, PenCTU and research network(s) to identify and set up the study in a timely manner, including, but not restricted to submission(s) for regulatory and Trust approval, site initiation as appropriate, Set up and maintain a study trial file for the project, and ensure responsibility for completion and/or maintenance of standards of documentation in accordance with the legislation. Participate in meetings with other centres involved in STEPS II Project and attend national and local investigator meetings to update knowledge and share data. Provide information and support to patients and carers relating to the research protocol, procedures and treatment, follow-up and ensure that informed consent is obtained.

Conduct all research trial procedures, assessments and data collection in strict compliance with the trial specific protocols and Trust policy and interpret these results to assess care needs. Maintain patient safety by reporting research adverse events in a timely manner; Contribute to developing and maintaining research Standard Operating Procedures and communicating any changes to those affected by them (e.g. the research team and supporting departments). Abide by the post holders relevant Professional Code of Practice Mandatory tasks Maintain patient safety through rigorous and consistent compliance with Trust policies for the prevention and control of infection, including hand hygiene.

To undertake mandatory annual training/updates in infection prevention and control. Safeguard and promote the welfare of children and young people in compliance with Trust and staff responsibilities under section 11 of The Children Act 2004; to follow Trust safeguarding and child protection policies and guidelines and undertake appropriate mandatory training and updates in safeguarding children/child protection. By following Trust Policies in relation to Safeguarding Adults, staff will ensure that they work with other agencies to protect all adults from abuse at any time. Respect and value the diversity of our patients, their relatives, carers and staff by committing to address the needs and expectations of the diverse communities we serve to provide high quality care, and strive to make best use of talents and experience from our diverse workforce.

COMMUNICATIONS AND WORKING RELATIONSHIPS Communicate complex, difficult and sensitive information at a time when the person they have approached may well be suffering from cognitive and communication difficulties. A sensitive, empathetic, skilled and experienced approach is essential. Ensure smooth running of STEPS II project across the Trust by communicating complex patient related information to healthcare professionals (e.g. in pharmacy, radiology, pathology) regarding patient condition and expected outcomes.

Deal with enquiries from other Health Care Professionals, patients and carers by providing specialist expert advice and support on al aspects of the trial protocol. Key working relationships: Clinical Teams Members Research and Development Office Staff Patients and Relatives/Carers including Clinical Research participants and their families Secretarial, Administrative and Clerical Staff Research Ethics Committee Clinical staff and research practitioners at Participant Identification sites. Clinical trial co-ordinators External auditors and regulatory inspectors as required MOST CHALLENGING PART OF THE JOB Working Conditions The post holder is required to present complex information to Study participant, clinical staff and members of the general public. Occasional exposure to unpleasant conditions (e.g.

body fluids, odours, lice) Some duties may be necessary after normal working hours therefore some flexibility required in work schedule Physical Effort The post holder will include seeing patients in all areas of the hospital. As such some walking is required. Light lifting duties (e.g. box files) would also be required.

Occasional requirement to manoeuvre patients and equipment for treatment. Occasional travel to other hospitals and/or research institutions in order to carry out the main duties of the post. Working on a computer each working day, which may mean being in a constrained position for lengthy periods of time. Mental Effort Work patterns are always unpredictable as it will depend on how many people come in that day and who may or may not be suitable for the research study being run.

Concentration is required to ensure that all protocol requirements are adhered to, data accurately recorded and that advice is accurately provided where required. Emotional Effort The post holder will be approaching patients and their families who may have had a condition which can be very debilitating. This may be distressing at times.