Senior Clinical Trials Coordinator

3 months ago

Cambridge, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

Job summary

We are looking for a Senior Trial Coordinator to be responsible for a portfolio of local and national cancer clinical trials contributing to cancer research. Your day-to-day job will involve working closely with Trials Coordinators and Data Managers, and also liaising with medical staff, pharmacists and statisticians involved in oncology trials. You will interact closely with chiefs investigators and Sponsor, set-up clinical trials, line manage a small team and report on your trial portfolio. The post is currently funded for 1 year. The role requires at least 2 days in the office

Main duties of the job

To line manage and support the Clinical Trials Coordinators in their assist the portfolio manager in managing the research portfolio and workload of the coordination team.

To develop and provide a fast, effective and supportive service to researchers to ensure high quality research is conducted in the unit.

To ensure that all GCP requirements are met in the conduct and coordination of clinical studies.

To coordinate Trust-sponsored clinical research.

This post is essential to ensure appropriate resources and staff are in place for the set-up, conduct and close-down of the studies and compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, and its amendments, with the Good Clinical Practice Guidelines ICH-GCP/ E6(R2), the NHS Research Governance Framework for Health and Social Care, the Data Protection Act, the Human Tissue Act and other applicable UK legislation and guidelines.

About us

Our Trust

Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 11000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.

CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.

Job description

Job responsibilities

Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.

This vacancy will close at midnight on the 22nd September 2024.

Interviews are due to be held on the 3rd October 2024.

Benefits to you

We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.

Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.

We welcome applications from the Armed Forces.

Person Specification

Qualifications

Essential

Educated to Degree level in health-related or biomedical science or with equivalent experience.

Desirable

Post grad degree in Clinical Trials, Epidemiology, study design or similar clinical trial related area.

Experience

Essential

Significant experience of working in clinical resarch, including observational studies and Clinical Trials falling under the EU Directive of Clinical Trials within the NHS and/or University. Substantial experience in the set-up, protocol development, coordination and management of clinical trials. REC, MHRA, R&D submissions and report writing. Grant applications & grant costing. Setting timelines and milestones. Experience of line management. Experience in managing a portfolio of trials.

Desirable

Experience of monitoring. Experience of document review. Experience of MHRA GCP Inspections and/or Sponsor Audits. Experience of leading meetings and informing best practices. Experience of developing new procedures and generating supporting SOPs. Experience of collaborating with the pharmaceutical industry in a clinical trial setting.

Knowledge

Essential

Significant knowledge of UK regulations, guidelines and requirements for the conduct of clinical research. Good understanding of specific requirements for clinical trials, NHS research governance and NHS/UK approval processes. Knowledge of study and protocol design, case report form and database design, and pharmacovigilance requirements. Knowledge of data protection requirements.

Desirable

Knowledge of Human Tissue act. Knowledge of Advanced Therapy Trials. IMP(GMP) and QP release.

Skills

Essential

Excellent communication and interpersonal skills including the ability to build working relationships with department colleagues, Trust staff at all levels and external organisations such as the Ethics Committees, Universities, funding bodies, and other NHS Trusts. Excellent organisational and planning skills. Ability to work under pressure balancing conflicting workloads. Ability to work independently with initiative and maintain confidentiality.

Additional Requirements

Essential

The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent. Work with enthusiasm and demonstrate initiative. Maintain up to date knowledge of changes in research governance and legislation with the ability to disseminate information to relevant parties.

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