Senior Clinical Research Practitioner

Job responsibilities

Clinical and Communication Responsibilities

Work autonomously to manage a large caseload of participants acting as a professional in ensuring a duty of care to the participants and their families.

Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical research protocol is adhered to at all times.

Devise, implement and evaluate strategies to identify eligible participants for the ROSSINI-Platform, including attending appropriate clinical meetings, disseminating knowledge and awareness of the trial amongst peers and relevant parties nationally. Support multiple sites to implement those strategies, with travel required to sites.

Participate in the informed consent process acting as a resource and support to sites and participants and their families.

Participate and support co-ordination of the relevant patient participation groups. Review and act on or feedback to the pillar and core teams relevant feedback from groups.

Coordinate the research participant pathway from screening for recruitment through to study closure.

Actively work to achieve study site and patient recruitment targets including engaging with the research team and site clinical teams to overcome barriers to participant enrolment.

Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.

Deal with concerns raised by participants and visitors in a proactive manner and take appropriate remedial action as necessary.

Responsible for accurate and timely completion of Clinical Report Forms (CRFs) and for ensuring that all data queries are dealt with in a timely and efficient manner.

Report to the governance team any clinical incidences and follow up to conclusion.

Act as a role model for excellence in research delivery.

Portfolio Management and Development

Review study protocols and identify resource implications for the sites.

Liaise with the medical team/sponsor organisation and co-ordinate follow up of participant where necessary.

Liaise with sites to ensure all site trial set-up actions have been completed.

Process amendments and disseminate information to sites.

Ensure participant recruitment data is being collected in a timely and accurate manner across sites.

Build strong professional relationships with other sites and BCTU to promote a good working environment and foster collaboration

Educate appropriate medical and nursing personnel and departments of the ROSSINI-Platform and protocol specific requirements.

Participate in the presentation of research findings and represent the ROSSINI-platform within the Trust and local Clinical Research Network, across sites and in relevant national specialty forum.

Monitor patient recruitment and data collection week by week, reviewing recruitment figures and alerting the lead research staff and Principal Investigators to any problems with recruitment.

Provide a monthly report of study activity and dissemination activity.

Team Management and Leadership

Act as a role model for excellence in research delivery

Lead and support the team acting as an expert resource, demonstrating tenacity, drive, professional integrity, balance and perspective.

Implement and work within the Trusts HR policies on all staffing matters, including sickness, capability and disciplinary issues. Take corrective measures if indicated in liaison with Human Resources and the Management Team.

Provide expert clinical research support to the clinical research team at the ROSSINI-Platform partner sites

Work with the other Band 7 Team Leaders in the Surveillance & Innovation unit and other Senior Clinical Research Practitioners on the other ROSSINI-Platform arms to provide adequate clinical oversight of the project

Keep records of staff involved on each partner site is kept up to date (including professional registration details and mandatory training)

Monitor performance of partner sites and ensuring Good Clinical Practice guidelines are followed and mandatory documentation is completed to required standard for a clinical research trial

Provide assurances that staff working on the ROSSINI-Platform have undergone the required minimum training as states in the Good Clinical Practice Guidelines.

Ensure accurate and timely management of research funding

Awareness of NIHR funding & financial management of the Cardiac arm of the ROSSINI-Platform

Provide assistance of the procurement of required resources and materials at the partner sites, if needed

Be aware of all Trust procedures and policies and collaborate with other health care professionals to ensure that these are observed.

Innovate and contribute to the development of Network wide clinical and research policies and procedures.

Develop and implement strategies to maintain and increase the level of participant recruitment at partner sites for the Cardiac arm of the ROSSINI-Platform as needed

Maintain the high profile of GSTT Research and Development and the ROSSINI-platform.

Work with the management team to ensure that the Trust is meeting the accrual targets for the ROSSINI-Platform and act to address any shortfalls.

Implement strategies and systems for quality assurance and actively contribute to internal and external audits and inspections.

Attend investigator meetings and conferences when required acting as an ambassador for the ROSSINI-platform and the Trust.

Education and Professional Development

Attend the training programmes and other relevant education and training days as agreed in your development plan.

Act in accordance with care certificate framework standards at all times.

Take personal responsibility for own professional growth and keep up to date with professional development and research.

Maintain a record to reflect any training carried out pertaining to the post and ensure direct reports maintain training files.

Prepare posters/research papers for meetings, conferences and publications.

Mentor and support other members of the team.

Act up for the Trust Lead for Surveillance & Innovation as required

Other responsibilities

Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.

Responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trials budgets.

Actively seek to develop the role to take account of changing requirements of the service.

Implement and adhere to relevant regulatory requirements related to study conduct.

Work collaboratively with colleagues across GSTT and the ROSSINI-platform to facilitate the achievement of objectives and shared learning.

Additional Information

Essential

• Flexible and positive approach to work
• Enthusiastic and highly motivated within field of research
• Committed to achieving research objectives

Skills/Knowledge/Ability

Essential

• Excellent communication and interpersonal skills and ability to deal with complex and sensitive situations.
• Able to provide highly specialist advice to participants and clinical teams
• Awareness of changing trends in healthcare and specialist area
• Up to date knowledge relevant to clinical research and good clinical practice
• In depth understanding of research methodologies
• Working autonomously at an advanced level
• Ability to lead, teach, supervise and mentor others in relation to all aspects of clinical research delivery
• Experience of producing written reports
• Ability to lead, teach, supervise and mentor others in relation to all aspects of clinical research delivery
• Willingness and ability to attend external meetings and/or make site visits pertaining to ROSSINI-Platform

Desirable

• Ability to carry out audit

Experience

Essential

• Significant experience in clinical research delivery including managing own portfolio of studies.
• Substantial experience relevant to speciality
• Knowledge and experience of handling complex relationships
• Experience mentoring, developing and supervising junior staff in clinical setting
• Experience in service development

Desirable

• Experience of change management
• Demonstrable managerial / team lead experience

Qualifications

Essential

• Registered Healthcare Professional (NMC, HCPC, GPhC)
• Good Clinical Practice (GCP)
• Completed Post graduate diploma / Level 7 study in specialty or related field
• Evidence of continuous professional development

Desirable

• Post graduate teaching qualification
• Registered on AHCS clinical research practitioner accredited register

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).