TCTU Portfolio Trial Coordinator (BE-GENOMICS) - UOD2363

TCTU Portfolio Clinical Trial Coordinator (BE-GENOMICS)

0.8 fte time, 36 months fixed term.

Part time, job share and secondment options will be considered

Grade 6 (£31,694 to £37,694)

We are seeking an enthusiastic individual to join TCTU as a Portfolio Clinical Trial Coordinator, playing a key role in our current portfolio of clinical trials. The post holder will provide support to TCTU Senior Trial Managers and other TCTU staff in the development, coordination and delivery of clinical trials which are being conducted by the TCTU. The role will involve all aspects of trial management and delivery including site initiation and training, monitoring and tracking site performance and data query management. The post holder must have excellent communication, organisation and administrative skills. Strong interpersonal skills are essential to the post as well as highly developed IT and computing skills. The ability to prioritise workload, establish and maintain e-systems, multi-task and work to tight deadlines and a willingness to work flexibly to meet varied demands of this busy role are required. While supporting the portfolio of TCTU trials, the post holder will provide dedicated support to the BE-Genomics trial, "A Clinical Trial of Genome Sequencing to identify treatable rare disease in bronchiectasis ", a UK wide trial being managed by TCTU.

Responsibility

Assist TCTU Senior Trial Managers and Trial Mangers with the drafting, design, formatting and preparation of trial documentation including protocol, patient information sheets, case report forms. This may include taking a lead on the drafting process as well as editing draft versions prepared by the team.

Acting as a point of contact for sites, assisting with site initiation and training, monitoring and tracking site performance and managing data queries.

Providing comprehensive support with the submissions and amendments for sponsor, ethical and regulatory approval.

Creating and managing systems to monitor study activity and resources locally and at sites, including facilities to track screening activity, enrolment, expiry dates of study consumables, stocks of template study documentation and promotional material at sites.

Design and maintain study specific web pages and trial branding material.

Process invoices and payments to trial collaborators, keeping accurate logs of all payments and manage any discrepancies/issues.

Maintain and monitor financial records and project progress reports.

Organise the preparation, outsourcing and dispatch of trial materials to collaborating partners, including the preparation of investigator site files, and promotional material.

Assist TCTU and trial team to identify sites and assessing suitability of resources and facilities at sites.

Setting up study sites ensuring that trial material are ready and available and necessary electronic logs are in place.

Supporting the study team with the preparation of reports.

Create and maintain paper and electronic trial master files.

Establish effective communication pathways, databases and systems and ensure dissemination of trial information within agreed timelines. This will include liaising with central and site clinical and administrative staff and regular updates of site contacts.

Organise and support local and international study meetings and conferences including preparation and circulation of relevant meeting materials, power point presentations and posters.

Develop communication strategies and systems for sharing information with the collaborating sites. Travel as required locally and to sites around the UK.

Supervise TCTU administrative staff as required.

To undertake any other task as required by TCTU Management within the level of the role. This may include providing support to the other division of TASC.

Ensure the TCTUs corporate image is maintained on study materials, publications, reports and to maintain the trial website

Working to TCTU and TASC SOPs and work instructions.

Keep abreast of new legislation and ensure that processes and standards for clinical trials are adhered to meet existing statutory / regulatory requirements.

Planning and Organising

* Prioritise own daily workload in accordance with the time lines and milestones.

* Be an active participant in regular planning and technical project meetings.

* Support the prioritisation of workload for the TCTU and clinical trial team.

* Advance planning to meet deadlines for dissemination and develop agenda and materials for project meetings e.g. reports/papers.

* Handle confidential communication and use discretion when communicating with relevant parties.

* Assist Trial Managers to ensure that trial documentation is communicated to sponsor, ethical and regulatory bodies, and investigators in order to meet existing statutory / regulatory requirements.

Problem Solving

* Proactively identify areas where systems and procedures can be improved and assist the TCTU team with implementation of best practice.

* Contribute to providing comprehensive solutions to issues relating to trial management, development, conduct and organisation.

* Ability to analyse, interpret and implement trial management solutions to meet the requirements of the trial.

* Resolve any trial co-ordination issues in a prompt and efficient manner.

* Ability to seek advice when required and identify own training needs.

* Manage unpredictable volumes of work and busy periods.

Decision Making

* Manage day to day issues as they arise and decide when it is necessary to refer outstanding issues to the CI or TCTU Senior Clinical Trial Manager.

* Proactively identify administrative tasks required to deliver the project on time and within budget, completing these with minimal supervision.

* Identify workload for delegation to administrative staff, monitor quality and provide/identify training needs.

Key Contacts/Relationships

* Strong working relationships are essential within the trial management team and across collaborating sites in order to share knowledge and ensure the smooth running of the trials.

* The post holder will be expected to organise, attend and contribute to relevant meetings relating to the study.

* Participate in the writing up, publication and dissemination of findings related to the research.

* The post holder must be able to interact with a wide range of people internally and externally, from a wide range of backgrounds using tact and judgement to deal with sensitive and confidential situations and personnel matters.

* Act as key contact in absence of trial managers and respond on their behalf to external collaborators and senior academics.