nhsjobs

Clinical Trial Data Manager @ Hull University Teaching Hospitals NHS Trust

Cottingham, HU16 5JQOnsiteContractPosted 9 days ago

Opens on nhsjobs

About this role

Job summary

o Provide a comprehensive data management service to the Academic Respiratory Medicine Department.

o 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.

o Perform data-gathering, ensure the departmental clinical trial management system is kept up to date and is current. Perform specified clinical tasks and administrative support for clinical research studies andresearch team

o Coordinate and input clinical trials data ensuring data is up to date and ensuring the completeness, accuracy and consistency of trial data in order to meet standards expected of sponsors and regulatory authorities

o Answer any queries specified on study specific database in a timely fashion

Main duties of the job

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.

You will gather data, provide administrative support for clinical research studies and research team, coordinate and input clinical trials data ensuring data is up to date and ensuring the completeness, accuracy and consistency of trial data in order to meet standards expected of sponsors and regulatory authorities.

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

For further details with regard to this vacancy opportunity, please see the attached Job Description and Person Specification.

We reserve the right to close the advert early in the event of high levels of interest. Therefore early applications are encouraged.

Please note that, in line with UKVI regulations, this vacancy does not meet the eligibility criteria for sponsorship under the Skilled Worker Visa route. As a result, we are unable to issue a Certificate of Sponsorship for this position.

We remain committed to fair and equal recruitment practices and encourage applications from all suitably qualified candidates who have the right to work in the UK.

Person Specification

Application Completion Essential

ALL sections of application form FULLY completed

Education/ 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 environmen

Desirable

Degree level education in related field

Knowledge, Training & Experience Essential

Considerable Administrative experience in clinical trials environment Base 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 Ability to prioritise own work load and delegate tasks as appropriate Appreciation of need for confidentiality at all times Producing material by utilising all areas of Windows software Experience of research databases, inputting patient data and answering queries

Desirable

Experience of multi agency working Knowledge of Respiratory Medicine Knowledge of Data Protection act and training

Communication and Interpersonal Skills Essential

Clear and concise documentation in hospital/medical notes Ability to collect and distribute trial data and study documentation, which is often of considerable volume

Desirable

Good Presentation and teaching skills along with excellent keyboard skills

Special Attributes and other Essential

Ability to remain calm and professional and cope with occasional exposure to distressing or emotional circumstances or work under pressure. Caring, friendly disposition Patient and understanding Able to work in a busy clinical environment as part of a multi-disciplinary team. Interested in personal development

Desirable

Ability to work without supervision in some areas: e.g telephone enquires and manage own case load

Other Requirements Essential

Ability to carry out research and development as a requirement of the job; Ability to facilitate a high quality research service Ability to meet the needs of staff, patients and carers involved in the research and development activity of the service. Ability 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:

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.

Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details Employer name Hull University Teaching Hospitals NHS Trust

Address Castle Hill Hospital

Castle Road

Cottingham

HU16 5JQ

United Kingdom

Employer's website https://www.hey.nhs.uk/ (Opens in a new tab)

Skills

Fixed-TermHealthcareNHS TrustNHSManagement

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