Research Co-ordinator

6 months ago

Liverpool, United Kingdom The Clatterbridge Cancer Centre NHSFT Full time

**The post holder will**: - Co-ordinate, support and manage set-up on a portfolio of research studies and activities hosted by The Clatterbridge Cancer Centre NHS Foundation Trust. Take a leading role in planning, co-ordinating the set-up of CCC-led trials, bringing project management and administrative expertise to the trial team and delivering permissions for studies on time and on target Assess research needs in each study and prepare an action plan. This will include, but is not be limited to, permissions for hosted non-commercially sponsored research projects and organising and delivering project management services for a portfolio of research studies. Co-ordinate regular update reports (including monthly to Sponsorship Group) progress on trials in set-up including all regulatory requirements.

Ensure that all regulatory reporting is up to date from the research studies and trials. Ensire that the CCC Edge Sponsor database is up to date and reflects all the information in the Trial Master File. Ensure that the Trial Master File is maintained and kept up to date. Co-ordinate meetings with the Chief Investigators at study inception and then through the life cycle of the research study.

Ensure all pharmacovigilance processes are followed and captured with any variances escalated. Ensure that clinical trials adhere to R&I specific Standard Operating Procedures, Directorate policies and procedures and Trust policies. Participate in the development of any training initiatives relating to Research and Innovation activities to ensure that the needs of the study teams are met. Provide expert advice for the CCC staff, non-commercial partners and clinical study teams on all aspects related to the legal and regulatory frameworks for the conduct of clinical trials in the UK.

Assist in the development of Standard Operating Procedures which guide the delivery of the R&I service, ensuring adherence to national and local policy and guidelines. Develop policies and protocols for own work area / proposes project changes which impact across the study teams. Liaise with internal departments and external organisations, as required, regarding project management staff needs and development. Maintain records and the CCC Edge database that records projects approval timelines, patient recruitment and amendments for trials.

Assist with trial set up and activation; establish procedures that ensure compliance with the protocol. Take overall responsibility for data management and quality assurance according to regulatory guidelines and requirements of individual trials (ICH-GCP and Data Protection Act 1998). This may involve supervision of data management within certain trials and studies. Establish good working relationships with local stakeholders and networks as appropriate.

Maintain regular contact with the Chief investigator and act as communication source between clinical trial management centres, Principle Investigators and clinical teams at site and any third party vendors. Ensure that trials recruit at an acceptable level at each centre and to resolve failures and implement strategies for improving recruitment. Produce progress reports on trials as necessary, under the direction of Research Governance and Quality Manager and Head of Reseach Governance and Sponsorship. Responsible for compliance with the regulations relating to confidentiality and Data Protection Act for Research Projects allocated.

Maintain expert professional practice through continuing education, professional updating and involvement with professional specialist groups. Prepare reports and presentations on all aspects of the research project. Leadership Oversee the CCC Edge systems to assure that R&I systems are legislatively compliance. Support the Research Governance and Quality Manager and Head of Research Governance and Sponsorship in trial set-up and management and Trust sponsored research Work to develop a culture of CCC led research across the Trust.

Training and supervision of junior staff. People management Provide project management skills in set-up and management of CCC-led research Act as key point of contact for day-to-day operations for CCC-sponsored research Ensure all reporting staff have up-to-date mandatory training. Communication To work closely with the clinical trials units and funders for CCC clinician-led studies. To develop and maintain good relationships, communication and teamwork with all disciplines and departments.

To communicate with representatives from external organisations as required. To provide both written and verbal reports as required. Communications and Relationships The postholder will be expected to communicate with a wide range of stakeholders including personnel, both internally and externally. The post holder must have excellent presentation skills with the ability to express coherent and convincing views, verbally and in writing.

To undertake the role will require developed communication skills to enab

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