Senior Clinical Trial Coordinator

The Royal Marsden NHS Foundation Trust; Greater London; On-site; GBP 35,000 - 45,000; Full time

Job summary

The Royal Marsden NHS Foundation Trust is seeking a Clinical Trials Coordinator to manage day-to-day running of allocated trials, ensuring regulatory approvals and adherence to GCP standards. The role involves coordinating submissions to REC, HRA, MHRA, and CCR, and supervising trial staff across units.

You will work across the Unit to implement systems, monitor portfolios, and ensure documentation is archived in line with SOPs.

Qualifications

• Recent GCP training.
• Life Sciences degree or relevant experience.
• Demonstrable experience of working in a clinical trial setting.
• Understanding of clinical trials and regulations governing clinical research.
• Desirable: trial set up/management experience in an academic institution/hospital.
• Desirable: experience of haematology/oncology.
• Able to work on both sites and to be flexible to meet the needs of the role.
• Willingness to travel within the UK and occasionally overseas to attend meetings and conferences.

Responsibilities

• Implement systems and processes within the Unit.
• Coordinate regulatory submissions to REC, HRA, MHRA and CCR for new research proposals.
• Ensure trials receive regulatory approvals before they commence.
• Supervise other clinical trial coordinators and administrators within the Unit as appropriate.
• Initiate and manage day-to-day running of allocated trials in accordance with GCP and RMH/ICR SOPs.
• Ensure appropriate archiving of trial documentation.
• Participate in the Trial Coordination Forum.

Skills

Prioritisation

Plan work

Self-management

Administrative skills

IT skills

Data entry

Communication

Interpersonal skills

Attention to detail

Problem solving

Education

Life Sciences degree

Relevant experience

Tools

Excel

PowerPoint

Microsoft Access

Job description

Detailed job description and main responsibilities

For further information please refer to the job description and personal specification

Primary areas of responsibility

These responsibilities will be carried out under the guidance of the operations manager.

Service Delivery:

• Responsible for implementation of systems and processes within the Unit.
• Under the direction of the Operations Manager/Senior Trial Manger to lead in implementation of systems within the Unit to ensure all Clinical Trials are conducted in accordance with all regulatory requirements including:
  • Medicines for Human Use (Clinical Trials) Regulations
  • Research Governance Framework for Health and Social Care
  • Human Tissue Act
• To coordinate the portfolio research meeting ensuring appropriate, documented monitoring of the clinical trial portfolio.
• To be a member of the Trial Coordination Forum.
• To supervise other clinical trial coordinators and clinical trial administrators within the Unit as appropriate.

Coordination of specific trials allocated to the Coordinator within the Unit's portfolio. Trial Set Up and Maintenance

• Initiate and manage day to day running of allocated trial(s) in accordance with GCP and RMH / ICR SOPs, policies and procedures.
• Complete applications to REC, HRA, MHRA and CCR for new research proposals.

Trial Conduct

• Responsible for ensuring all research within the clinical unit receives all relevant regulatory approval before it commences.
• Responsible for ensuring the Unit's Clinical Research Portfolio is conducted in accordance with all regulatory requirements.

Trial Closure

• Ensure trial closure is notified to Clinical R&D Office, Sponsor, REC, HRA and MHRA as appropriate.
• Ensure appropriate archiving of trial documentation.

Person specification

Education/Qualifications

Essential criteria

• Recent GCP training
• Life Sciences (or equivalent) degree or relevant experience

Experience/Knowledge

Essential criteria

• Demonstrable experience of working in a clinical trial setting
• Understanding of clinical trials and regulations governing clinical research

Desirable criteria

• Experience of trial set up/management experience in an academic institution/hospital
• Experience of working in the field of haematology/oncology

Skills/Abilities

Essential criteria

• Ability to prioritise workload and adjust own work in light of unexpected events or changing priorities.
• To be able to use own initiative planning own work and work unsupervised where appropriate.
• Excellent administrative and organisational skills
• Excellent IT skills including access, excel and power point
• Experience of data entry and data management
• Excellent oral and written communication skills
• Ability to interact with, influence an motivate people at all levels
• Ability to interact confidently with experts and non-experts alike
• Good attention to detail
• Ability to maintain adherence to written procedures
• Experience of problem solving

Desirable criteria

• Experience of supervising administrative staff

Other Requirements

Essential criteria

• Able to work on both sites and to be flexible to meet the needs of the role

Desirable criteria

• Willingness to travel within the UK and occasionally overseas to attend meetings and conferences

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. Please ensure your information is accurate to avoid errors with processing your application

All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails.

Flu Vaccination - What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.