Job Description

Work with the Research Team to support the safe conduct of research in accordance with the UK Clinical Trials Regulations and Good Clinical Practice (GCP) and provide assurance that the rights, safety and well-being of trial participants are protected. The post holder will be responsible for undertaking, coordinating and driving a team in the recruitment of patients to clinical trials. The post holder will work with the team lead to develop and grow the research portfolio across their designated specialty area. The post will involve managing and coordinating clinical trials collaboratively with the research & multidisciplinary teams. Be accountable for the assessment, planning, organisation and on-going care of research participants, whilst maximising compliance with study/trial protocol. As a specialist role the post holder will provide expert direction, support, supervision and management of staff. They will assist with the training of staff to ensure they conform to protocol and practice guidelines. The role will be key in problem solving and solution driving issues, to ensure research is conducted safely, effectively and efficiently by all members of their team. The post holder will coordinate our services with various healthcare partners, and be prepared to adhere to flexible working patterns to meet service needs of protocol. The post holder will coordinate their team to meet local targets and meet departmental objectives.

Responsibilities

• Coordinate and support a team to increase research portfolio growth over designated specialties.
• Assess and evaluate the progress of ongoing clinical trials and research undertaken in the department maintaining accurate records of the status of studies.
• Provide specialist advice and support to other members of the multidisciplinary team about ICH GCP and HRA and other legislative requirements.
• Give information in a format the patient understands and answer questions fully for the patient to make an informed decision.
• To receive and document consent when given by the patient as appropriate.
• Coordinate and attend study visits.
• Be responsible for the assessment, planning and ongoing care and safety for a patient through their study journey.
• Centrifuge, process, track and ship blood samples in line with study protocol.
• Collaborate with sponsors, study monitors and external bodies to ensure the study is meeting acceptable standards.
• Collect and record highly accurate data whilst adhering to the data protection act.
• Escalate and record adverse events and suspected unexpected serious adverse events that occur whilst the patient is on the study in line with the study protocol.
• Communicate effectively.
• Work autonomously using own initiative and collaboratively across the research and multidisciplinary team involved in the research process.
• Be directly responsible for coordinating a team and portfolio of studies.
• Undertake an annual appraisal.