Detailed job description and main responsibilities

Responsible to the Head of Research and  Research Operations Manager

KEY TASKS & RESPONSIBILITIES:

Research
• To identify strategies for the screening and recruitment of participants into clinical studies.
• To ensure that all research staff in the study team are working within the parameters set out by the study protocols and according to the standards of UK Policy Framework for Health and Social Care Research and principles of ICH-GCP.
• To oversee the informed consent process of studies ensuring patient’s rights are protected throughout the course of the study.
• To register/randomise participants into studies and ensure that all participant study data is collected in a timely, accurate, and consistent way, ensuring that members
of the clinical study team are following local policies and procedures.
• To identify barriers to recruitment to studies and ensure that the management team is made aware of them.
• Work with staff to develop and implement strategies as required to overcome the barriers.
• Oversee the local feasibility of studies, plan their set up including review of cost implications prior to delivery of studies and within the required timeframe.
• Ensure the R&I delivery team members perform the closure and archiving of studies in a timely manner as per study sponsor requirements and departmental policies and procedures.
• Ensure amendments to studies are enacted in a timely manner.
• To provide support for clinical studies colleagues in their absence, as required.
• To work with clinical study team and other health care professionals in identification of suitable studies, taking account of available resource to expand/maintain the research and innovation portfolio.
• To identify potential investigators to expand the local research and innovation portfolio.
• To ensure any deviation/violation of study protocol and/or ICH-GCP is reported to the sponsor and the senior management team using relevant platforms of reporting, in a timely manner.
• To assist in the production of a regular R&I newsletter across for local distribution.
• Liaise with sponsor organisations, systems partners and industry to develop the research and innovation portfolio.

Management
• To work with the R&I Operations manager in the provision of a comprehensive research service across FHFT and system partners.
• To allocate resources to ensure the safe delivery of the clinical studies service on a daily basis.
• Provide strong leadership to the R&I delivery team.
• To contribute to the development of departmental policies and procedures and ensure that policies and procedures are adhered to across the research team.
• To keep up to date on staff and departmental issues liaising with the Operations Manager and disseminating relevant information to the team.
• Oversee the safe introduction of studies into clinical practice ensuring all relevant personnel are adequately trained and competent with the procedures required by the studies protocol.
• Oversee the R&I delivery team to ensure liaison with the members of the multidisciplinary team and support departments to establish procedures for the safe and smooth running of clinical studies.
• Monitoring and ensuring that the study recruitment accruals are correctly credited on EDGE and NIHR research data platform.
• To conduct the appraisal review process of the staff under direct line management and ensure all in within R&I delivery team are appraised in a timely manner.
• Ensure efficient recruitment and induction of new staff following departmental guidance.
• Ensure staff line management follows Trust policies and liaises with HR, where required.
• Ensure EDGE data is up to date as per departmental requirements.
• Attend meetings relevant to the nature of the job and provide regular reports , as required

 CLINICAL RESPONSIBILITIES

• To manage own studies, and to supervise the R&I delivery team, as required, in the management of their studies as per UK Policy Framework for Health and Social Care Research and ICH-GCP.
• To attend multi-disciplinary meetings, and appropriate clinics, to screen and recruit new participants and to share your expert knowledge with the members of the MDT,as required.
• To ensure that the study related information and support is given to participants in a timely, accurate, and consistent manner.
• To ensure that study specific investigations are undertaken as required by the studies protocol, to establish eligibility and safety to enter the studies.
• To ensure the safe administration of treatments and drugs as per study protocol.
• To ensure patient samples are collected, processed, stored and transported, and as required by the study protocol and laboratory manual.
• To ensure that patient data is collected and recorded on to EPIC and case report forms of studies in a timely, accurate, and consistent manner.
• Monitor treatment toxicity/side effects and escalate any changes to the clinical team, as required by the protocol.
• To ensure recording and reporting of all adverse events in accordance with the relevant local, departmental, study sponsor and national regulatory  requirements.
• To ensure participant follow-up is conducted as per study protocol