Clinical Practice § Maintain patient and research subject confidentiality at all times. § Assist research team in administrative.....
Clinical Practice § Maintain patient and research subject confidentiality at all times. § Assist research team in administrative duties for clinical trial start-up, initiation, maintenance, and study closure. § Work with the Research department to ensure compliance with regulatory requirements. § Assist in the entry of accurate and timely documentation of data in patient Case Report Forms (CRFs) either on paper or electronic versions. § Assist the research team and monitors the resolution of raised data queries. § Assist the research teams in the maintenance of the trial site file e.g. collating and filing paperwork, obtaining signatures for the delegation log. § Assist the research team in the entry and maintenance of accurate information on databases such as the patient recruitment database. § GCP Training and IATA Training § Working on commercial and non-commercial studies and Pharmaceutical companies adhering to their research protocols and ensuring the studies are delivered effectively. § Attend Investigator meetings and Site Initiation meetings as appropriate. § Working closely with the Yorkshire and Humber Clinical Research Network. § Under supervision, or independently after the appropriate training, carry out clinical procedures required for clinical trials including but not limited to : blood pressure recordings, heart and respiratory rate, height, weight and BMI assessment, collection of blood and urine samples, measurement of hip/waist circumference and conducting ECGs. § Report all findings from clinical procedures to the clinical research team and accurately document as advised by the team in appropriate research files, logs, case report forms and databases. § Process blood and urine samples according to clinical trial protocols such as: Preparing blood slides, serum separation using a centrifuge and pipetting to separate blood and serum samples. § Preparing these samples for ambient or frozen storage and shipment as directed and arrange couriers for the safe and timely transport of all clinical samples. § Helping to run searches on electronic system, to highlight suitable patients for studies. § Assisting with monitoring visits for studies, when CRAs attend site. § Reading research protocols and SOPs. Communication Demonstrate sensitive communication styles to ensure patients are fully informed and consent to treatment. Communicate with and support patients receiving ‘bad news’. Communicate effectively with patients and carers, recognising the need for alternative methods of communication to overcome different levels of understanding, cultural background, and preferred ways of communicating. Anticipate barriers to communication and take action to improve communication. Estimate and maintain effective communication with individuals and groups within the practice environment and with external stakeholders. Act as an advocate when representing patients and colleagues. As directed, assist research participants in completing trial-related assessments such as paper questionnaires or using electronic data capture devices. Delivering a Quality Service Produce accurate, contemporaneous, and complete records of patient consultation, consistent with legislation, policies, and procedures. Prioritise, organise, and manage own workload in a manner that maintains and promotes quality. Participate in the maintenance of quality governance systems and processes across the practice. Utilise the audit cycle as a means of evaluating the quality of the work of self and the team, implementing improvements where required. Collaborate on improving the quality of healthcare in partnership with other clinical teams, responding to local and national policies and initiatives as appropriate. Evaluate the patients’ response to healthcare provision and the effectiveness of care. Support and participate in shared learning across the practice and wider organisation. Participate in the management and review of patient complaints and identify learning from clinical incidents and near-miss events using a structured framework (e.g. root-cause analysis). Assess the impact of policy implementation on care delivery. Participate in the performance monitoring review of the team, providing feedback as appropriate. Understand and apply legal policy that supports the identification of vulnerable and abused children and adults, being aware of statutory child/vulnerable adult health procedure and local guidance. Work within policies regarding family violence, vulnerable adults, substance abuse and addictive behaviour, and refer as appropriate. Ensure all patient identifiable records for clinical trials are stored according to information governance policies. Assist with maintenance/ordering of research supplies, reporting of faulty equipment. Leadership – personal and people development Take responsibility for own development learning and performance including participating in clinical supervision and acting as a positive role model. Actively promote the workplace as a learning environment, encouraging everyone to learn from each other and from external good practice. Encourage others to make realistic self-assessment of their application of knowledge and skills, challenging any complacency and actions that are not in the interest of the public and/or users of services. Participate in planning and implementing changes within the area of care and responsibility. Contribute and participate in the development of local guidelines, protocols, and standards. Participate in the planning and engagement of practice-based commissioning or similar initiatives. Ensure awareness of sources of support and guidance (e.g. PALS) and provide information in an acceptable format to all patients, recognising any difficulties and referring where appropriate. Arrange monitoring visits for external monitors and assist in the preparation and follow up of these visits. Arrange patient clinic appointments with the research team and trial participants as required. Assist the research team in the preparation and conduct of clinic visits for patients enrolled in clinical trials. To develop, implement and audit co-ordinated pathways of care for patients receiving treatment within a clinical trial. Team Working Understand own role and scope and identify how this may develop over time. Work as an effective and responsible team member, supporting others and exploring the mechanisms to develop new ways of working. Delegate clearly and appropriately, adopting the principles of safe practice and assessing competence. Ensure clear referral mechanisms are in place to meet patient need. Prioritise own workload and ensure effective time-management strategies are embedded within the culture of the team. Work effectively with others to define values, direction and policies impacting upon care delivery. Participate in team activities that create opportunities to improve patient care. Participate in and support local projects as agreed with the practice management team. Management of Risk Manage and assess risk within the areas of responsibility, ensuring adequate measures are in place to protect staff and patients. Monitor work areas and practices to ensure they are safe and free from hazards and conform to health, safety and security legislation, policies, procedures, and guidelines. Ensure safe storage, rotation and disposal of vaccines and drugs. Oversee the monitoring, stock control and documentation of controlled drug usage according to legal requirements. Support members of the nursing team to undertake mandatory and statutory training requirements. Apply infection-control measures within the practice according to local and national guidelines. Apply policies that reduce environmental health risks, are culturally sensitive and increase access to health care for all. Participate in the local implementation strategies that are aligned to the values and culture of general practice.
