As a Clinical Trials Assistant-experienced, your main duties will include: Clinical Duties Provide a safe environment for staff and service users having due regard to legislative and study procedure requirements. Contribute to the equity of care for all individuals. Assist the research team in the delivery of planned clinical research activities, working to evidence-based care. Prepare and collate relevant documentation and equipment for each study visit, including source data forms, questionnaires, investigation request forms, blood/tissue collection equipment etc.
Support participants and carers during recruitment and participation in studies. Administer questionnaires and diaries to trial participants, providing clear instructions and oversight with appropriate supervision. This may involve telephone assessments or face-to-face visits. Undertake delegated tasks without direct supervision where/when appropriate.
This may require the use of observational/analytical skills to monitor the health and well-being of participants. Take and record vital observations e.g. blood pressure, heart rate, respirations, temperature, physical measurements e.g. measuring waist circumference, weight, performing urinalysis, obtain blood samples, centrifuge blood samples and manage and coordinate the packing and shipping of biological samples.
In addition, they may also be required to perform other tests and procedures commensurate with the role. Work collaboratively with other healthcare professionals and agencies to deliver a high standard of care. Maintain awareness of the health and safety issues regarding the handling/exposure to bodily fluids when caring for participants. Understanding and adhering to infection control and cold-chain guidelines.
Ensure any concerns regarding the patients are referred to appropriate clinical colleagues at the earliest opportunity. Undertake all such reasonable other duties as may be required as part of the role. Use appropriate information to make timely and effective decisions about clinical research participants. Obtain, process and transport biological samples related to clinical research activities following the trial laboratory manual.
Participate in the use of information and technology needed for the delivery of clinical research activities. Provide information in a form that meets the understanding of the receiver at all levels. Use oral, written, or computerised information that facilitates research activity following standard operational procedures and study procedures. Complete documentation following organisational policy and procedures.
Support the receipt, storage, accountability and reconciliation of investigational medicinal products, in accordance with study Protocols, pharmacy manuals and local SOPs. Professional Duties Impart plans and instructions clearly and effectively. Carry out administrative procedures in compliance with the principles of Good Clinical Practice and all regulatory legislation and local SOPs. Establish clear lines of communication at all levels.
Communicate relevant and factual information to participants and carers, using sensitivity and tact. Contribute to the understanding of patients in situations of communication difficulties. Maintain patient and professional confidentiality at all times. Contribute to a working culture which is open to change, new ideas, concepts, and innovation whilst reflecting organisational strategy and values.
Willing to develop new skills and participate in training and development of new team members, acting as mentor when required. Be flexible, motivated and will have a keen interest in pursuing a wider knowledge and understanding of clinical research in a primary care setting. Attend and contribute to meetings held by the team and the organisation. Support site monitoring activities including preparation for monitoring visits, responding to data queries and filing of follow-up documentation.
Performance & Finance Duties Assist the research team to log activities within the appropriate management reporting systems such as EDGE, to allow invoices to be generated accordingly. Complete invoices accurately at the required time intervals and ensuring payment is received. General Duties Seek advice and support from the research team or line manager whenever necessary. Maintain professional conduct, including appearance at all times.
Ensure maintenance of Professional Registration/Qualifications e.g.GCP. Maintain adequate participant records and ensure all relevant information is documented in the participants medical notes. Accurately document data collected into the case report forms. In association with the local clinical team, ensure that all adverse events are recorded and appropriately reported.
Obtain any missing data and resolve queries with the clinical investigators and trial management office. Record and circulate meeting minutes. Create study proformas. Ensure study amendments are implemented in a timely manner.
Maintain Investigator site files and essential study documentation in line with GCP and sponsor requirements. The post-holder maybe required to undertake any other duties. This job description is not exhaustive and may be added to or changed to from time to time following discussion and consultation with the post holder and line manager.