An exciting opportunity has arisen for a Multiple Sclerosis (MS) Clinical Trials Coordinator to join our dynamic MS Team. The post will offer the opportunity to support the team in recruiting patients to trials and carry out all aspects of administration related to the day to day running of clinical trials.

The successful candidate will preferably have experience in clinical trials and data management. Experience working in the field of Multiple Sclerosis is desirable. They will also have excellent communication and organisational skills and the ability to work autonomously and as part of a team.

Treatments for MS are a rapidly developing area and it is an exciting, growing field to be working in.

You will have access to in house educational programmes.

Main duties of the job

To support the Multiple Sclerosis team in all aspects of administration and governance related to clinical trials. Carry out responsibilities that are related to the day to day running of clinical trials to ensure quality is maintained.

To identify and recruit study participants, ensuring that each participant fulfils the study criteria and understands the implications of participation when making effective informed consent.

About us

We are a thriving Foundation Trust at the heart of an integrated healthcare system. One that delivers improved patient care at a community, hospital and specialist setting, supported by a unique and nationally recognised programme of research, education and employee engagement.

We expect all our staff to share the values that are important to the Trust, being Excellent, Kind, Responsible & Respectful, and behave in a way that reflects these.

St George's University Hospitals NHS Foundation Trust is committed to safeguarding children and vulnerable adults and expects that all staff will share in this commitment. The Trust is clear that all staff have a responsibility to be aware of children and adult safeguarding policies and procedures and that each member of staff, clinical and non-clinical, will attend child or adult safeguarding training that is provided at an appropriate level to suit their role. The Trust has the additional expectation that all staff will be able to identify concerns and know what action to take.

Job description

Job responsibilities

• Initiate and manage the day to day running of allocated trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)
• To complete applications to Research Ethics Committees (REC), Medicines and Healthcare products Regulatory Agency (MHRA) and Research and Development (R& D) for new research proposals. This will include:
• Assisting the Principal Investigator (PI) and the Senior Nurse with feasibility and expressions of interest in their delegated portfolio.
• Ensuring that trials do not commence until all regulatory, sponsor and local R& D requirements are satisfied.
• Ensure trial specific responsibilities delegated by the Sponsor to the PI are carried out in accordance with the specific contract. Ensure that this correlates to the information recorded on the delegation log and is accordance with protocol guidance.
• Responsible for correct version control of all documentation. Prepare and submit amendments, as required and update trial documentation as necessary e.g. protocols, investigator brochures, case report forms.
• Ensure all allocated Site Files are ready to be reviewed by MDT and regulatory bodies. Ensure that electronic and paper documents are stored appropriately and are easily accessible by the team.
• As a member of the multi-disciplinary team (MDT) ensure recruitment of patients to trials are carried out appropriately. This will include:
• Attending relevant/allocated MDT meetings, highlighting eligible patients, completing and processing relevant screening logs.
• Tracking patients (this will include screening clinics) and ensure informed consent procedures are followed, file consent forms appropriately and document on recruitment log.
• Inform Trials Office and complete randomisation as required.
• In collaboration (or independently) with the clinical team ensure all schedule requirements are organised and completed as per protocol requirements.
• Responsible, in collaboration with the MDT, for ensuring that CRFs (Case Report Forms) both paper and electronic, are accurately completed in a timely manner. Ensure that confidentiality is maintained and adhere to the Data Protection Act. Within the allocated portfolio the post holder will work independently on several studies.
• Ensure that high quality is maintained, by demonstrating minimum data query requests. Take action to complete missing data as required and ensure efficient procedures are in place to improve data capture. Able to discuss concerns with the CRF Nurse Manager and implement changes to improve quality.

Person Specification

Qualifications

Essential

• Life sciences degree, or equivalent experience

Desirable

• Recent GCP training or qualification in research/clinical trials

Experience

Essential

• One year experience of data entry and data management

Desirable

• Experience in the NHS

Skills

Essential

• Excellent oral and written communication skills
• Excellent IT skills including access excel and power point

Desirable

• Experience of Clinical laboratory work

Employer details

Employer name

St George's Healthcare NHS Foundation Trust

Address

St George's Hospital

London

SW17 0QT

Any attachments will be accessible after you click to apply.

200-5597448-PT