Job summary
The Faculty of Health Sciences invites applications for a Clinical Trials Co-Ordinator within the Respiratory Research Group within Hull York Medical School (HYMS) based at Castle Hill Hospital.
The Respiratory Medicine Group was founded in 1998 with the appointment of Professor Alyn Morice as foundation chair. Respiratory Medicine has an extensive background and history of conducting clinical research. Areas of research undertaken include our speciality area chronic cough, asthma, chronic obstructive airways disease, bronchiectasis, idiopathic pulmonary fibrosis and cystic fibrosis. The clinical trials unit is a very busy unit, which has a dedicated team of Research nurses and associates led by the Clinical Trials Manager.
This post requires a criminal record check through the Disclosure and Barring Service.
Main duties of the job
Provide a comprehensive administration service to the Academic Respiratory Medicine Department.This role will involve working closely with clinical Investigators, Research Nurses and other members of research teams to maintain holistic support for the department, thus facilitating a high quality research service.The successful candidate will be required to provide technical and administrative support within the Respiratory Medicine Clinical Trials Unit under the on-site supervision of the Clinical Trials Manager. Experience of clinical trials research would be beneficial.
About us
The Humber Health Partnership is one of the largest acute and community Partnership arrangements in the NHS, seeing well over one million patients every year and managing a budget of over £1.3 billion.
Made up of two Trusts - Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) and Hull University Teaching Hospitals NHS Trust (HUTH) - our Partnership has significant ambitions and is committed to delivering world-class hospital and community services for the 1.65 million people we serve.
Together we employ nearly 20,000 staff. Our five main hospital sites are Diana, Princess of Wales Hospital, Scunthorpe General Hospital and Goole and District Hospital, for NLAG and Hull Royal Infirmary and Castle Hill Hospital for HUTH.
As Teaching Hospitals working with the Hull York Medical School, we both lead and contribute to research in many areas - biomedical research, primary care, palliative medicine, cardiovascular and respiratory medicine, vascular surgery, cancer surgery and oncology.
We believe that by developing a diverse, inclusive, innovative, skilled and caring workforce, we can deliver excellent care to our patients and a great future for our employees, our Partnership and our community.
Job description
Job responsibilities
Completion of all documentation relating to research patient participation including hospital records, Case Report Forms (CRFs) and electronic research records.
Respond to data queries in a timely manner.
Ensure relevant documents are available for all research patients, adhering to Medical Records tracing systems.
Participate in the research departments administrative and clerical procedures as necessary.
Work closely with Clinical Investigators, Research Nurses, R&D and other members of research teams to maintain holistic support for all clinical trial participants, thus facilitating a high quality research service.
Liaise and communicate effectively with external stakeholders (CRN, Hull Health Trials Unit, Pharmaceutical Companies) to ensure quick set up and smooth running of clinical trials and enhance the reputation of the department.
Job description
Job responsibilities
Completion of all documentation relating to research patient participation including hospital records, Case Report Forms (CRFs) and electronic research records.
Respond to data queries in a timely manner.
Ensure relevant documents are available for all research patients, adhering to Medical Records tracing systems.
Participate in the research departments administrative and clerical procedures as necessary.
Work closely with Clinical Investigators, Research Nurses, R&D and other members of research teams to maintain holistic support for all clinical trial participants, thus facilitating a high quality research service.
Liaise and communicate effectively with external stakeholders (CRN, Hull Health Trials Unit, Pharmaceutical Companies) to ensure quick set up and smooth running of clinical trials and enhance the reputation of the department.
Person Specification
Qualifications
Essential
- Educated to diploma level or equivalent standard in subjects relevant to role
- Ability or willingness to undertake additional training to degree level or equivalent knowledge & experience in Respiratory research environment.
Desirable
- Degree level education in related field
Knowledge
Essential
- oConsiderable Administrative experience in clinical trials environment
- oBase level of theoretical knowledge of ICH-GCP clinical trial standards and the detailed trial-specific rules it provides for administration and record keeping - if formal training not already undertaken, willingness to undertake training course to acquire this knowledge within 3 months of starting in post
- oAbility to prioritise own work load and delegate tasks as appropriate
- oAppreciation of need for confidentiality at all times
- oProducing material by utilising all areas of Windows software packages. Publisher, Excel, PowerPoint etc...
Desirable
- oExperience of multi agency working
- oKnowledge of Respiratory Medicine
- oKnowledge of Data Protection act and training
communication
Essential
- oClear and concise documentation in hospital/medical notes
- oAbility to collect and distribute trial data and study documentation, which is often of considerable volume
Desirable
- oGood Presentation and teaching skills along with excellent keyboard skills
Personal Qualities
Essential
- oAbility to remain calm and professional and cope with occasional exposure to distressing or emotional circumstances or work under pressure
- oCaring, friendly disposition
- Patient and understanding
- oAble to work in a busy clinical environment as part of a multi-disciplinary team.
- oInterested in personal development
Desirable
- oAbility to work without supervision in some areas: e.g telephone enquires and manage own case load
Analytical
Essential
- oAbility to identify and highlight local activities that might impact on achievement of the Service's aims:
R&D
Essential
- oAbility to carry out research and development as a requirement of the job;
- oAbility to facilitate a high quality research service:
- oAbility to meet the needs of staff, patients and carers involved in the research and development activity of the service
- oAbility to formulate documentation prior to an ethics committee submission:
- oAbility to collect and collate trials data and complete trial documentation, maintaining all Study Site Files to ICH-GCP standards and in a condition that would pass inspection by the medicines and healthcare Products regulatory Agency
- oAbility to use web-based data collection and statistics collection tools and Excel spreadsheets.
Miscellaneous
Essential
- oAble to attend national and international trial meetings
- oFlexible approach to hours and conditions
Person Specification
Qualifications
Essential
- Educated to diploma level or equivalent standard in subjects relevant to role
- Ability or willingness to undertake additional training to degree level or equivalent knowledge & experience in Respiratory research environment.
Desirable
- Degree level education in related field
Knowledge
Essential
- oConsiderable Administrative experience in clinical trials environment
- oBase level of theoretical knowledge of ICH-GCP clinical trial standards and the detailed trial-specific rules it provides for administration and record keeping - if formal training not already undertaken, willingness to undertake training course to acquire this knowledge within 3 months of starting in post
- oAbility to prioritise own work load and delegate tasks as appropriate
- oAppreciation of need for confidentiality at all times
- oProducing material by utilising all areas of Windows software packages. Publisher, Excel, PowerPoint etc...
Desirable
- oExperience of multi agency working
- oKnowledge of Respiratory Medicine
- oKnowledge of Data Protection act and training
communication
Essential
- oClear and concise documentation in hospital/medical notes
- oAbility to collect and distribute trial data and study documentation, which is often of considerable volume
Desirable
- oGood Presentation and teaching skills along with excellent keyboard skills
Personal Qualities
Essential
- oAbility to remain calm and professional and cope with occasional exposure to distressing or emotional circumstances or work under pressure
- oCaring, friendly disposition
- Patient and understanding
- oAble to work in a busy clinical environment as part of a multi-disciplinary team.
- oInterested in personal development
Desirable
- oAbility to work without supervision in some areas: e.g telephone enquires and manage own case load
Analytical
Essential
- oAbility to identify and highlight local activities that might impact on achievement of the Service's aims:
R&D
Essential
- oAbility to carry out research and development as a requirement of the job;
- oAbility to facilitate a high quality research service:
- oAbility to meet the needs of staff, patients and carers involved in the research and development activity of the service
- oAbility to formulate documentation prior to an ethics committee submission:
- oAbility to collect and collate trials data and complete trial documentation, maintaining all Study Site Files to ICH-GCP standards and in a condition that would pass inspection by the medicines and healthcare Products regulatory Agency
- oAbility to use web-based data collection and statistics collection tools and Excel spreadsheets.
Miscellaneous
Essential
- oAble to attend national and international trial meetings
- oFlexible approach to hours and conditions
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.
