University College London Hospitals NHS Foundation Trust
The NIHR UCLH Clinical Research Facility is a well-established Clinical Research Facility covering two sites; a comprehensive Cancer and Medical research facility on the Bloomsbury campus (BC) at 170 Tottenham Court Road, and the Leonard Wolfson Experimental Neurology Centre is a dedicated neuroscience experimental medicine facility at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square (QS).
We are looking to recruit a self-motivated and enthusiastic Clinical Trials Coordinator (CTC) to work in the CRF and be responsible for leading on the set-up and implementation of commercial and academic clinical trials, liaising with study teams, service departments, study sponsors, the NIHR CRN: North Thames and the Joint Research Office (JRO) to ensure trials are set up in a timely manner and run efficiently at the CRF. The post holder will also process amendments and will have a key role in making sure that study information is maintained on databases to accurately reflect CRF activity. The post holder is responsible for ensuring the regulatory aspects of clinical trials are maintained to Good Clinical Practice (GCP) standards.
The post holder will be based across both CRF sites according to the needs and requirements of the busy and dynamic study portfolio.
Main duties of the job
1. Lead on the set-up of trials within the CRF across a variety of specialities and an expanding portfolio.
2. Prepare documentation and apply for ethics, Competent Authority and HRA approvals, local feasibility, Assess Arrange and Confirm requirements, and NIHR CRN adoption including substantial amendments, as required.
3. Assist with project costings at the proposal stage, monitor trial grants, review expenditure against budget and ensure adherence to terms of all relevant contracts, in collaboration with relevant CRF staff and the JRO.
4. Act as the key and central point of contact for trial specific queries, and support trial Principal and Chief Investigators throughout the clinical trial process, including supporting Site Qualification and Initiation Visits as needed, monitoring visits, collating and distributing essential trial paperwork and other tasks related to trial progress at all stages of the trial life-cycle.
5. Act as liaison between JRO, PI, sponsor and/or CRO to ensure that any queries are dealt with in a timely manner.
6. Execute SLA's and reviews with support departments and other Trusts.
7. Oversee, facilitate and actively engage in data collection, data entry/management, statistical analysis, report writing and trial archiving activities - contributing directly to those activities as required.
Person Specification
Knowledge and Qualifications
* First degree in scientific/healthcare related discipline or equivalent experience.
* Comprehensive understanding of UK Clinical Trials Regulations, the European Directives on Clinical Trials and the UK Policy Framework for Health and Social Care Research.
* Familiar with the regulatory processes in the UK required for authorising, conducting and terminating clinical research.
* Excellent working knowledge of Good Clinical Practice (GCP) and good knowledge and understanding of other related standards such as Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP).
* Excellent working knowledge of EU pharmacovigilance requirements.
Experience
* Significant experience of working in a clinical trials setting.
* Experience of setting up commercial and noncommercial clinical trials.
* Experience of working in a pharmaceutical company, contract research organisation, academic clinical trials unit or similar organisation.
* Experience of preparing regulatory and ethics submissions, writing/amending protocols, Participant Information Sheets, case report forms and other relevant trial management documentation.
Skills and Abilities
* Excellent administrative and organisational skills.
* Ability to prepare reports Resourceful and able to act on own initiative, checking with the line manager when appropriate.
* Flexible and supportive approach to team working, and a proactive approach to develop and document systems and procedures.
* Outstanding organisational skills, managing several projects that are often time pressured, concurrently. Ability to prioritise activities in spite of conflicting pressures.
* Ability to summarise scientific data/information.
* Ability to maintain adherence to written procedures.
* Keen to remain up to date with current and new research legislation and guidance and willing to undertake further training related to this as required.
* A willingness to undertake further training as necessary and relevant to meet the needs of the department/team.
* Excellent IT skills, including Word, Excel, PowerPoint, Access/databases and the Internet/email.
Communication
* Ability to write in a scientific, concise, technical and cohesive manner.
Personal and People Development
* Demonstrates ability to lead and mentor.
* Demonstrates coaching skills.
Responsibilities towards promoting Equality Diversity and Inclusion
* Demonstrates willingness to treat others with dignity and compassion. Places a high value on diversity and fairness. Understands the Equality Act 2010, duties, roles and responsibilities.
Other requirements
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, per annum inclusive of HCAS.
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