Clinical Trials Associate/Coordinator

Job title:

Clinical Trials Associate/Coordinator

Company

NHS

Job description

The NIHR UCLH Clinical Research Facility is a well-established Clinical Research Facility covering two sites; a comprehensive Cancer and Medical research facility 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 an enthusiastic and self-motivated Clinical Trials Associate/Coordinator to join the NIHR UCLH Clinical Research Facility. This position involves playing a key role in setting up and conducting clinical trials from early-stage through to phase 3 and experimental non-IMP studies. The role includes trial set-up/close-out activities, processing amendments, managing participant screening and recruitment and data management.Main duties of the jobKey responsibilities will include coordinating with trial Principal Investigators and other stakeholders, ensuring timely data collection and query resolution, maintaining portfolio databases, and preparing documentation for ethics and regulatory approvals. You will also be involved in project costings, monitoring trial grants, and ensuring compliance with financial contracts. The role requires the development and maintenance of databases, statistical analysis, and preparation of scientific manuscripts and reports.The post holder will work closely with the CRF Clinical Studies Manager and senior management team, as well as with a wide range of internal and external partners, including the Joint Research Office, pharmaceutical companies, and other research organizations. You will also be responsible for line management of junior staff, contributing to the development of SOPs, and ensuring high standards of record-keeping and patient confidentiality.We seek a proactive individual with strong project management skills and experience in clinical research coordination. If you are passionate about clinical research and have excellent communication and organizational skills, we encourage you to apply. The post holder will be based across both CRF sites according to the needs and requirements of the busy and dynamic study portfolio.About usUniversity College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.We provide first-class acute and specialist services across eight sites:University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)National Hospital for Neurology and NeurosurgeryRoyal National ENT and Eastman Dental HospitalsUniversity College Hospital Grafton Way BuildingRoyal London Hospital for Integrated MedicineUniversity College Hospital Macmillan Cancer CentreThe Hospital for Tropical DiseasesUniversity College Hospital at Westmoreland StreetWe are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women’s health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.Date posted04 October 2024Pay schemeAgenda for changeBandBand 6Salary£44,806 to £53,134 a year Per Annum Inclusive of HCASContractPermanentWorking patternFull-timeReference number309-UCLH-5234Job locationsNIHR UCLH Clinical Research Facility4th Floor, 170 Tottenham Court Road,LondonW1T 7HAJob descriptionJob responsibilitiesFor the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description. This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found athttps://www.nhsemployers.org/articles/pay-scales-202425Come and be a part of the best NHS trust in England to work for, according to our staff*UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work. Job descriptionJob responsibilitiesFor the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description. This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found athttps://www.nhsemployers.org/articles/pay-scales-202425Come and be a part of the best NHS trust in England to work for, according to our staff*UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.Person SpecificationQualificationsEssential

• First degree in scientific/healthcare related discipline or equivalent experience

Knowledge and ExperienceEssential

• Significant experience of working in a clinical trials setting
• Experience of setting up commercial and noncommercial clinical trials
• 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)
• 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.

Desirable

• Excellent working knowledge of EU pharmacovigilance requirements.

Skills and AbilitiesEssential

• 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
• 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

CommunicationEssential

• Ability to write in a scientific, concise, technical and cohesive manner

Personal and People DevelopmentEssential

• Demonstrates ability to lead and mentor

Desirable

• Demonstrates coaching skills

Other requirementsEssential

• Good eye for detail

Person SpecificationQualificationsEssential

• First degree in scientific/healthcare related discipline or equivalent experience

Knowledge and ExperienceEssential

• Significant experience of working in a clinical trials setting
• Experience of setting up commercial and noncommercial clinical trials
• 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)
• 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.

Desirable

• Excellent working knowledge of EU pharmacovigilance requirements.

Skills and AbilitiesEssential

• 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
• 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

CommunicationEssential

• Ability to write in a scientific, concise, technical and cohesive manner

Personal and People DevelopmentEssential

• Demonstrates ability to lead and mentor

Desirable

• Demonstrates coaching skills

Other requirementsEssential

• Good eye for detail

Expected salary

£44806 – 53134 per year

Location

Fitzrovia, Central London

Job date

Sun, 06 Oct 2024 06:03:20 GMT

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