Job summary
Employer heading
Trial Coordinator - Maternity (Family Health Research)
Band 6
Job overview
The Post holder will support the management and maintenance of the Family Health clinical trials portfolio coordination predominantly within the field of Maternity, but where applicable could support the wider Family Health research portfolio. This will include data management and administrative functions within designated research team(s) delivering information, tools and processes that support the effective management of the portfolio of research within the team(s).
The primary aims of the post are to:
· Facilitate the management of research feasibility assessment
Ensure the efficient and timely initiation and delivery of clinical research
· Ensure the implementation, standardisation and optimisation of quality, financial and data systems
· Support divisional activity and performance reporting
Main duties of the job
• Act as a pivotal point of contact with internal and external stakeholders such as commercial study sponsors and representatives.
• Under the direction of the Clinical Research Team Leader be responsible for and participate in the administrative set up and ongoing administrative management of all clinical trials within the team.
• Implement and ensure maintenance of systems to track the status of the research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within a designated team.
• Responsible for ensuring clinical report forms and other data capture mechanisms are completed efficiently and effectively within agreed timeframes.
• Development of team reporting mechanisms to measure data capture/entry against agreed performance metrics.
• Development of actions plans to address any actual or potential deviations from agreed data capture metrics.
• Ensure team, divisional and national study targets are achieved within agreed timeframes
• Liaise with Trust departments regarding trial feasibility and resource requirements.
• In collaboration with the Clinical Research Team Leader work with internal and external sponsors and their representatives to ensure timely collection and management of trial related data.
Working for our organisation
With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!
We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.
Detailed job description and main responsibilities
Research
• Act as a pivotal point of contact with internal and external stakeholders such as commercial study sponsors and representatives.
• Under the direction of the Clinical Research Team Leader be responsible for and participate in the administrative set up and ongoing administrative management of all clinical trials within the team.
• Implement and ensure maintenance of systems to track the status of the research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within a designated team.
• Responsible for ensuring clinical report forms and other data capture mechanisms are completed efficiently and effectively within agreed timeframes.
• Development of team reporting mechanisms to measure data capture/entry against agreed performance metrics.
• Development of actions plans to address any actual or potential deviations from agreed data capture metrics.
• Ensure team, divisional and national study targets are achieved within agreed timeframes
• Liaise with Trust departments regarding trial feasibility and resource requirements.
• In collaboration with the Clinical Research Team Leader work with internal and external sponsors and their representatives to ensure timely collection and management of trial related data.
• In conjunction with the Clinical Research Team Leader collate and provide relevant information relating to the capabilities of the assigned team in preparation for strategic partnership meetings.
• Oversee the archiving process for all clinical trials, ensuring adherence to the current Trust archiving guidelines.
• To support with clinical activities in line with own capabilities and within Trust policies.
• To provide direct line management for junior staff including responsibility for recruitment, retention, disciplinary and grievance and all human resource related staffing issues as required
• Ensure the annual performance review and identification of developmental needs are conducted in accordance with Trust policy
• Support and contribute to the education and training needs of the research teams, ensuring the objectives of Research & Innovation and the Trust are reflected
• Contribute to the assessment and allocation of the workforce requirements to support the effective maintenance and management of the portfolio of research within the designated team
• Provide leadership within the team and act as a role model and resource for all team members
• Ensure all line reports are clear about what is expected and are working together in successful teams to achieve the Trust’s vision
• Maintain own professional development and identify learning needs and opportunities
• Participate in Trust wide education programmes and study days, regional and national meetings and research seminars as appropriate
• Oversee induction training, support and mentoring for new post holders within the team
• Participate and lead on continued training and development of staff across the research division
Financial Management
• Support contract negotiation processes with trial sponsors under direction from the Clinical Research Team Leader, ensuring appropriate financial agreements are in place for each project for both commercial and non-commercial research studies
• Ensure the business processes and systems for financial management are implemented, such as service line reporting, invoicing, procurement, activity logs etc.
• Adopt responsive working practices in relation to any new financial processes/systems that require implementation
• Produce written activity and annual reports under the direction of the Clinical Research Team Leaders
Person specification
Training and Qualifications
Essential criteria
- Postgraduate qualification or equivalent demonstrable experience
Desirable criteria
- Knowledge of research governance and regulations (e.g. ICH-GCP and EU Directives)
Experience
Essential criteria
- Significant proven experience of working within clinical trials.
- Proven experience of clinical research/trials or relevant exposure or understanding of research.
- Experience of working in multidisciplinary teams
- Experience of working across professional and organisational boundaries
Desirable criteria
- Previous experience of research work in a related research area.
- Experience of the research approval process
Communication and relationship skills
Essential criteria
- Excellent interpersonal verbal and written communication skills
- Experience of dealing with conflict and non-compliance successfully
- Ability to communicate complex, study related information to patients and their families, sometimes in highly stressful environments
Desirable criteria
- Experience delivering training as core part of previous employment
- • Experience of conference or other presentation
Analytical and Judgement Skills
Essential criteria
- Ability to stick to protocols and procedures and yet willing to work in a no-blame, honest environment at times of protocol violation
- Able to identify, extract and process complex health information from a variety of sources
Desirable criteria
- Demonstrable success of having to make judgement calls in difficult situations
Planning and Organisational Skills
Essential criteria
- Able to plan and carry out role under minimal supervision
- Able to plan workload and liaise with colleagues to promote safety and achieve continuity of care
- Approachable / able to work under own initiative
- Experience of leadership skills and ability to deputise for senior team.
Desirable criteria
- Involvement in clinical innovation or service development in previous roles
Physical skills
Essential criteria
- Able to use computer work stations for large proportion of working day as required
- Willingness to attend meetings and training events locally and nationally, including out of hours
Applicant requirements
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
Documents to download
Further details / informal visits contact
- Name
- Helen Navarra
- Job title
- Research Delivery Manager Family Health
- Email address
- [email protected]
- Telephone number
- 07812268084
- Additional information
Yvette Davis Maternity Research Team Leader
07812275194
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