Clinical trials coordinator

NHS; London; On-site; GBP 44,000 - 54,000; Full time

Job description

Guy's and St Thomas' NHS Foundation Trust

We are looking for an enthusiastic and experienced senior research coordinator to join our team on a 12 month fixed term maternity cover basis.

The post holder will be responsible for leading the provision of a full administrative and coordination research service across the Gastrointestinal Medicine & Surgery directorate. They will have a pivotal role in the set up and feasibility of a portfolio of in-house, national and international clinical studies. They will oversee invoicing and research finance for non-commercial research studies. They will coordinate studies in setup and work with the delivery team and R&D to manage protocol amendments.

Responsibilities will include managing research budgets and staff, undertaking study feasibility assessment and leading on public engagement. Further to this the post holder will monitor recruitment processes, implement change where necessary and maintain high standards at all times. The post holder will ensure confidential and sensitive information is kept secure, and that all work will be carried out in accordance with both the Trust's policies and Good Clinical Practice (GCP) regulations. The post holder will work closely to the GMS Research Matron and R&D Lead, GMS research team and the GSTT R&D teams.

Main duties of the job

1. Invoicing and financial oversight management
2. Coordinating and managing a large portfolio of studies in setup
3. Managing amendments
4. Feasibility assessment and support local C&C assessment
5. Overseeing study close down and managing archiving
6. Supporting the research delivery team
7. Leading and overseeing procurement

Job responsibilities

This role will offer the post holder an opportunity to work closely with experienced clinical and research colleagues from across the trust, supporting a varied portfolio of non-commercial research studies. Successful candidates will be brilliant at communication with a range of teams and professionals, able to manage their time well and confident in research governance. Previous clinical research experience is essential. You will be joining an enthusiastic, friendly, and motivated multidisciplinary team in a dynamic teaching hospital in central London, and you will be an essential member of the research team.

Role includes:

1. Invoicing and financial oversight management
2. Research governance and maintaining GCP
3. Coordinating and managing studies in setup from feasibility to end of study
4. Implementing and managing amendments to existing studies.
5. Feasibility assessment and support local C&C assessment
6. Organising Site Initiation Visits
7. Overseeing study close down and managing archiving
8. Supporting the research delivery team
9. Overseeing procurement and ordering of consumables
10. Acting as main point of contact for enquiries relevant to trial set up.
11. Facilitating governance project board meetings on a monthly basis to discuss new research proposals.
12. Updating EDGE/EPIC with recruitment when needed
13. Confirming recruitment for sponsored studies on CPMS
14. Playing a pivotal role in the monitoring and development of current local Standard Operating Procedures to ensure that they are fit for purpose and accurately detail procedures for study processes.
15. Providing guidance and expertise on research set up, through development of specialist, in-depth knowledge.
16. Working with the Principal Investigators, Research delivery team, R&D and management to ensure the successful set up of new studies.
17. Supporting and guidance to new staff as appropriate in all area of study delivery/governance and provide training where necessary
18. Providing regular updates on the progress of new studies
19. Managing and prioritising their own workload
20. Going through the researcher checklist handbook with new researchers
21. Organisation of Investigator site file prior to sponsor greenlight including version control, localisation, signed delegation logs.
22. Co-leading the patient Research Advisory Group

There are excellent opportunities for further education and leadership development within this role, including training and an individual personal development plan. The normal working hours for the post are 9am-5pm but this can be discussed and there are opportunities for flexible working arrangements. The posts are mainly based at Guys Hospital but there will be cross site travel required to other sites such as St Thomas Hospital.

Person Specification

• Degree in life sciences or related field
• 2-3 years experience in clinical research or R&D

Experience

• Experience in clinical research, research delivery or R&D
• Experience of working independently and as part of a team

Skills, knowledge and abilities

• Proven ability to make decisions, organise and prioritise own work in a busy work environment and time critical situations
• In-depth knowledge about clinical trial coordination including approvals process
• Ability to manage invoicing and finance oversight
• Ability to communicate effectively within a multidisciplinary team

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Salary

£44,806 to £53,134 a year pro rata inc HCA

Contract

Fixed term

Duration

12 months

Working pattern

Full-time

Reference number

196-RD276

Job locations

Guy's and St Thomas NHS Foundation Trust