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Senior Clinical Trials Coordinator
4 months ago
**Main area**
- Division R&D - Cambridge Cancer Trials Centre**Grade**
- Band 7**Contract**
- 12 months (Fixed Term for 12 months)**Hours**
- Full time
Part time
Flexible working
Home or remote working
37.5 hours per week (Full Time or Part Time/ Flexible working hours may be considered. 2 days in the office (not fully remote))**Job ref**
- 180-F-245203**Employer**
- Cambridge University Hospitals NHS Foundation Trust**Employer type**
- NHS**Site**
- Addenbrookes Hospital-Division R&D**Town**
- Cambridge**Salary**
- £43,742 - £50,056 p.a. pro rata**Salary period**
- Yearly**Closing**
- 22/05/2024 23:59**Interview date**
- 13/06/2024Job overview
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 roles.
To 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.
Working for our organisation
**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.
Detailed job description and main 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 May 2024.
Interviews are due to be held on the 13th June 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.
Person specification
**Qualifications**:
Essential criteria
- Educated to Degree level in health-related or biomedical science or with equivalent experience.Desirable criteria
- Post grad degree in Clinical Trials, Epidemiology, study design or similar clinical trial related area.Experience
Essential criteria
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.
Setting timelines and milestones.
Experience of line management.
- Experience in managing a portfolio of trials.Desirable criteria
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 criteria
Significant knowledge of
