Detailed job description and main responsibilities

Please see Full JD for more descriptions. 

The Post holder will:

• Act as an expert resource and is responsible for ensuring all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or IS0 14155, as appropriate, whether conducted personally or through appropriate delegation. 
• Be responsible for ensuring the feasibility procedures undertaken are sufficient to ensure all studies undertaken are within the scope of the unit and the available resources.
• Will utilise expert knowledge to ensure appropriate methodologies are employed in the execution of research.
• Support the PI and trials team in obtaining ethical permissions, including completing IRAS / MHRA (Drug and/or devices) and local ethics submission.
• Be responsible for ensuring all studies are registered with the R+D department and that full Trust approval, in addition to ethics approval, has been obtained prior to commencement of the study.
• Work with the R+D department in contract negotiations
• Liaise with the NIHR Regional Research Delivery  Network (previously Clinical Research Network) throughout the study and facilitate the lines of communication between the Trust / R+D and the NIHR RRDN.
• Has a comprehensive knowledge of the financial issues relating to the undertaking of clinical research.
• Be expected to undertake detailed costing of studies to ensure all costs related to the study are identified prior to Trust approval being given.
• Involved in the financial processes associated with co-ordinating research studies and grant application.
• Have the ability and drive to initiate and / or undertake original research.
• Be responsible for project managing all the studies in set up,
• Is expected to identify any blockages to study set up and work with R+D to identify strategies to mitigate them.
• Is expected to establish and update Standard Operating Procedures and supporting the development of local and national policies for research.
• Ensure compilation and maintenance of all site files, in accordance with ICH-GCP.
• Maintain a register and documentation of ICH-GCP for all research active staff, including documentation of ongoing training pertaining to their specific studies.

Clinical Trial Running

• Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations
• Ensure correct maintenance of Investigator Site File(s) and completion of Case Report File / eCRF with a high degree of accuracy.
• To understand and apply in practice the legal and regulatory requirements related to gaining and maintaining valid informed consent. This will include, where appropriate, children, young people, and vulnerable adults.
• Project manage the assignments to ensure all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol.
• Acts in the best interests of the research subjects to ensure their rights are upheld.
• Ensure Protocol amendments are incorporated into research practice.
• Acts as an expert resource for staff in relation to the financial management of clinical research studies.
• Uses expert judgement in relation to competing demands for funding / resources
• Acts as an expert resource to PIs in ensuring all Adverse Events and Serious adverse events are reported in line with ICH-GCP, ISO 14155 and Trust policy.
• Is expected to identify any blockages to recruitment and the running of the trial and work with R+D, and where appropriate liaise with the NIHR Regional Research Delivery Network, to identify strategies to mitigate them.
• Ensure that all equipment used in all the trials are appropriately calibrated and be responsible for the retention of supporting documentation.
• Support the PI in ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner.
  • Be responsible for ensuring the submission of monthly recruitment / accrual figures to the appointed person at NBT / NIHR Regional Research Delivery Network.
• Works within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.
• Always observes the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations.
• Communicates to R+D / NIHR Regional Research Delivery Network lead regarding research subjects, trial progress, workload issues and personal development.