Job summary
The Research Administrator will provide support in a clinical and academic research environment for the delivery of clinical research studies both within the Clinical Research Facility and throughout the Trust.
The post holder will be responsible for capturing complex clinical data from medical records and research documentation, entering data into eCRF systems ensuring the data is recorded accurately and submitted in a timely manner. The role will involve communication with research teams within the Trust and external agencies such as pharmaceutical companies. The post holder will have a portfolio of clinical studies for which you act as a point of contact for queries from the trial monitor, providing coordination support and working collaboratively with the lead consultants and lead research nurses.
The post holder will be responsible for study start up activities and preparation of study documentation relating to: clinical study timelines for all studies conducted in the CRF, recruitment plans and strategy, informed consent forms, and clinical metrics reports. You will assist the Research Co-ordinators in the preparation of the submissions and local tracking of applications, ensuring collection, review, tracking and provision of appropriate clinical documents to support regulatory submission.
Main duties of the job
- Manage the Research Governance mailbox and where required allocate enquires to appropriate members of the Governance team as necessary. Field queries (e.g., guidance on ethics applications, sponsorship queries, general research queries etc.)
- Process study amendments as they become notified through the Research Governance mailbox adhering to Standard Operating Procedure
- Process honorary contracts for non-GOSH staff to allow them to conduct research at GOSH and as per the process guidelines.
- Responsible for providing support to the clinical and non-clinical teams during set-up, maintenance, and close-out of clinical studies.
- Assist with the coordination, completeness, and accuracy of NIHR/HRA documents and submissions - distribute documents to investigational sites or vendors as required.
- Document management, assist in uploading study documents such as amendment packages, regulatory approvals, final reports and other relevant reports onto Edge.
- Prepare and maintain Investigator Site Files throughout the study lifespan, ensuring these are tidy and up to date
- Ensure Tracking databases are up to date along with entering study information into databases where appropriate.
- Support the Research Coordinators in relevant administrative tasks.
- Arrange, attend, and record minutes for specialty research meetings and other relevant departmental meetings.
About us
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination.
We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.
We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.
We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.
We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Person Specification
Academic/Professional qualification/Training
Essential
- Qualified to 'A' Level/NVQ Level 3 standard or equivalent
- Knowledge of health information management acquired through a relevant specialist qualification or equivalent experience of information handling and analysis gained in a work environment
- Educated to degree level in a relevant discipline (i.e. science, health, health management, social science)
Culture and Values
Essential
- Our Always values oAlways welcoming oAlways helpful oAlways expert oAlways one team
Experience/Knowledge
Essential
- Experience of working on multiple parallel tasks to strict and often tight deadlines
- Experience of managing information systems and developing databases and spreadsheets
- Experience of analysing complex information from databases and generating reports
- Relevant secretarial/administrative experience (ideally in a health care setting)
- Knowledge of the Data Protection Act
- Experience of setting up and managing filing systems
Desirable
- Experience of working in a clinical trial environment in either a pharmaceutical company, NHS Trust or a university
- Knowledge and understanding of the Department of Health's Research Governance Framework
Skills/Abilities
Essential
- Numerate with advanced IT skills (MS Office applications - Access, Excel and PowerPoint)
- Excellent verbal and written communication skills, with the ability to interact effectively with staff at all levels
- Able to handle sensitive and/or confidential information
- Able to transcribe data in a timely and consistently accurate manner with excellent attention to detail
- Able to work calmly under pressure in order to manage an unpredictable workload and perform to tight deadlines
- Ability to extract, compile and interrogate data
- Able to make sound judgments, use own initiative and work with minimal day-to-day supervision
Desirable
- Experience in study start up activities
Person Specification
Academic/Professional qualification/Training
Essential
- Qualified to 'A' Level/NVQ Level 3 standard or equivalent
- Knowledge of health information management acquired through a relevant specialist qualification or equivalent experience of information handling and analysis gained in a work environment
- Educated to degree level in a relevant discipline (i.e. science, health, health management, social science)
Culture and Values
Essential
- Our Always values oAlways welcoming oAlways helpful oAlways expert oAlways one team
Experience/Knowledge
Essential
- Experience of working on multiple parallel tasks to strict and often tight deadlines
- Experience of managing information systems and developing databases and spreadsheets
- Experience of analysing complex information from databases and generating reports
- Relevant secretarial/administrative experience (ideally in a health care setting)
- Knowledge of the Data Protection Act
- Experience of setting up and managing filing systems
Desirable
- Experience of working in a clinical trial environment in either a pharmaceutical company, NHS Trust or a university
- Knowledge and understanding of the Department of Health's Research Governance Framework
Skills/Abilities
Essential
- Numerate with advanced IT skills (MS Office applications - Access, Excel and PowerPoint)
- Excellent verbal and written communication skills, with the ability to interact effectively with staff at all levels
- Able to handle sensitive and/or confidential information
- Able to transcribe data in a timely and consistently accurate manner with excellent attention to detail
- Able to work calmly under pressure in order to manage an unpredictable workload and perform to tight deadlines
- Ability to extract, compile and interrogate data
- Able to make sound judgments, use own initiative and work with minimal day-to-day supervision
Desirable
- Experience in study start up activities
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.
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).
Additional information
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.
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
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street Hospital
30 Guilford St
London
WC1N 1EH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
