Responsibilities
- Clinical Trial Management (CTIMPs and Non-CTIMPs): Obtain informed consent from participants for non-CTIMP studies (i.e., observational and questionnaire) as instructed by the Principal Investigator (PI) and within protocol parameters. Support participants considering taking part in interventional and observational research, ensuring they have full understanding of the study and their information needs are met sensitively.
- Adverse events reporting: Ensure all Adverse Events are reported in line with the Trust Adverse Events Reporting policy and that reporting to regulatory bodies and Research Networks (if applicable) is timely.
- Communication and governance: Facilitate and maintain written and verbal communication between the PI, research and clinical teams to ensure correct protocol implementation and adherence to research governance standards. Ensure equipment is appropriately calibrated and supporting documentation is retained.
- Clinical procedures: Perform visits, observations and clinical procedures per the study protocol, including monitoring vital signs, body measurements, height and weight, ECGs, venepuncture, cannulation, and drug administration with participants. Undertake laboratory work as per study protocols, including processing, packaging, storing and transportation of samples.
- Participant support and data management: Provide ongoing support to patients and volunteers regarding trial participation. Maintain clinical trial databases and logs, including updating recruitment data on EDGE (Local Performance Management System) weekly. Incorporate protocol amendments in a timely manner.
- Standards and governance: Work within research guidelines, ethical principles and protocols, while adhering to organisational policies and procedures. Maintain patient confidentiality in accordance with the Data Protection Act and Caldicott regulations.
- Clinical governance and safeguarding: Lead on assessing, planning and implementing high quality care; lead on complex clinical care; ensure safe custody, maintenance and administration of medication in line with Trust policy. Promote a safe therapeutic environment and incident/infection control practices; apply escalation procedures and risk management.
- Teamwork and quality improvement: Promote safeguarding policies, work with colleagues to deliver care, coordinate specialist functions, and monitor quality of care in line with CQC requirements and Trust objectives. Deliver and supervise a high-quality patient experience and contribute to data collection on quality indicators.
- Resource and safety management: Maintain a safe working environment, ensure equipment is safe and used per policy, manage stock control, and oversee the use and maintenance of physical resources (e.g., computers, office equipment). Embed risk management as part of daily roles.
- Education and development: Attend induction and mandatory training, participate in research-specific training (e.g., GCP), contribute to team meetings and learning sessions, maintain a research training log, and develop knowledge in line with governance, GCP, and EU directives. Identify learning needs and pursue opportunities; support development of junior staff and contribute to training events.
- Site initiation and close-out support: Support Site Initiation Visits and assist in study feasibility discussions, costing of studies, and identifying barriers to trial setup. Ensure site files are maintained according to ICH-GCP and assist with study close-out and data clarification as needed.
- Administrative and study documentation: Set up and maintain investigator site files, complete Case Report Forms (CRFs) and eCRFs accurately, set up and maintain study trackers, manage amendments, and locate and track medical records. Participate in audit/monitoring visits and filing of research material (labs and imaging).
- Miscellaneous: Manage patient valuables and expenses, support stock control, and ensure responsible use of resources to support research activity.
Notes
Please refer to the attached Job Description and Person Specification for a full list of role requirements and main responsibilities. LNKD1_UKTJ