Clinical Research Team Leader( Research Midwife)

Job responsibilities

Clinical & Research

• To facilitate efficient, safe and participant focused research including screening procedures, biological sample collection, and all clinical observations required to ensure and maintain patient safety before, during and after the research visit.
• To take responsibility for ensuring patient facing equipment is maintained in line with Trust policy
• To ensure all research staff (registered and unregistered) practice safely according to Trust policy, including the facilitation and recording of all mandatory and specific study related training.
• To ensure biological samples are kept according to GCP and Trust standards.
• To review new studies for your specialist areas and lead on initial study feasibility.
• To lead on the set up, coordination and management of the local portfolio of clinical research studies
• Demonstrate sound knowledge of the life cycle of a research project from inception to study close out and performing all clinical protocol related tasks independently to include
• Provide comprehensive advice and guidance on matters relating to research ethics and governance
• Take an active role in contributing to local recruitment strategies, identifying required workforce and skill mix to deliver local portfolio
• Ensure Good Clinical Practice and research governance standards for clinical research are adhered and maintained
• Act as an expert resource for staff, researchers and research participants, providing an in-depth knowledge of aspects pertinent to acquiring and maintaining informed consent.
• To facilitate the informed consent process and contributes to the monitoring of consent procedures
• Ensure the processes and procedures for participant confidentiality are developed and adhered to according to Trust policy.
• To be responsible for the delivery teams compliance of data ensuring study data is collated and transferred in a timely manner
• To identify barriers to recruitment and implement necessary action plan
• To act as a knowledgeable resource for staff and researchers on matters relating to clinical practice and research, promoting an active and effective research culture.
• To use specialist knowledge to manage the clinical research team, prioritising workload according to changing needs in line with local and national guideline
• In conjunction with the Principle Investigator provide a suitable and safe environment for the physical and psychological well-being of staff, patients and their relatives
• To delegate tasks and activities to a range of team members in relation to ensuring safe planning and care of patient
• To recognise and act on concerns raised if research deviates from the study protocol or the study design conflicts with legal requirements

Operational Management

• Provide professional and clinical leadership to the research teams
• To be a key player in the feasibility process of new studies in your clinical area
• To take a lead role in the study set up process, being aware of research costs and support the speedy set up of gaining local permission for research studies
• To lead on ensuring studies meet time and target, identifying barriers to recruitment and implementing and monitoring action plans
• To ensure research study costs are recorded in a timely manner and attributed to the appropriate cost centre
• To initiate and develop Standard Operating Procedures within your department
• To ensure effective communication systems are in place for staff and to facilitate timely information flows to internal and external stakeholders
• To ensure study records and trial files are maintained and kept up-to-date
• To ensure all clinical study documentation is presented accurately with localised headings and correct version numbers
• To ensure clinical study amendments are processed according to local policy
• To ensure the clinical research recruitment records are accurately maintained and research staff are informed of the progress in accordance with trust policy
• To ensure that clinical studies are effectively archived as required

Leadership, Staff Management

• Provide research and clinical leadership across the whole spectrum of the research pathway
• Actively raise the profile of clinical research by educating clinical staff and patients about research
• To ensure all nursing staff are registered with the appropriate nursing body and all staff have the appropriate skills to undertake clinical research tasks
• To provide professional, supportive leadership with underpins the trusts values and behaviours
• To ensure and monitor adherence to the full range of trust policies and procedures
• To ensure all staff under your line management have annual personal and professional development review (PDR) according to local policy
• To lead on recruitment and retention initiatives and recruit new staff in line with local policy
• Monitor and support trust policies and procedures, i.e. sickness and absence, grievances and disciplinary
• Maintain your own personal and professional development keeping updated with current practice
• Lead in the education and support of health care professionals to enable them to care for research participants
• To maintain effective communication and working relationships with all internal and external research members
• Maintain an awareness of changes within the health service and the implications of these for clinical research
• Lead and attend team, local and national meetings as appropriate
• To support student nurses/midwives and AHPs on placement

This job description may be subject to change according to the varying needs of the service. Such changes will be made after discussion between the post holder and his/her manager.

All duties must be carried out under supervision or within Trust policy and procedure. You must never undertake any duties that are outside your area of skill or knowledge level. If you are unsure you must seek clarification from a more senior member of staff.

Trust Values

Essential

• Putting patients first
• Responsive to, and supportive of, patients and staff
• Open, welcoming and honest
• Unfailingly kind, treating everyone with respect, compassion and dignity
• Determined to develop our skills and continuously improve the quality of care

Education and Qualifications

Essential

• Current NMC registration (Midwife/Nurse) or Registered CRP
• Master's Degree/working towards MSc or equivalent experience
• Teaching qualification or equivalent experience
• Evidence of on-going personal and professional development
• Leadership training/education
• GCP Certificate holder (current)

Experience

Essential

• Relevant clinical and research experience at Band 6
• Understanding of National Institute of Health Research (NIHR), its values, aims and structure
• Experience of commercial research
• Understanding of the Research Governance Framework and ICH GCP
• Proven knowledge of research study set up and local approvals processes
• Experience of supervision of junior staff and Human Resources process
• Experience and understanding of change management and facilitation of these processes
• Experience of establishing and developing effective relationships with key stakeholders
• Extensive experience in the consent process for patients entering clinical trials
• Competent in storing and retrieving electronic data

Desirable

• Understands the importance of financial and budgetary management

Skills and knowledge

Essential

• Highly developed leadership skills with the ability to influence individuals both within and outside the organisation
• Demonstrates passion for excellence
• Proven teaching and assessing skills
• Ability to function as an autonomous practitioner
• Ability to apply current research to practice
• Expert knowledge of clinical research methodology and trial protocols and to communicate this to professionals and lay persons
• Flexible in their attitudes and behaviours to support team working and delivery of objectives
• Proven ability to use own initiative
• Proven ability to deal with complex situations
• Proven ability to communicate with patients and their relatives
• Able to teach, support, nurture and guide new starters and students
• Proven ability to communicate at all levels

Personal qualities

Essential

• Energetic and proactive
• High level of personal and professional integrity
• Patient and kind
• Strong interpersonal, negotiating and influencing skills
• Confident and articulate
• Supports Trust PROUD values at all times

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).