Job overview
The Research Administrator will provide support in a clinical and academic research environment for the delivery of clinical research studies within the Haematology/Oncology Trials team and throughout the Trust.
The post holder will be responsible for supporting study start up activities and preparation of study documentation relating to clinical study timelines for all studies conducted in the Haematology/Oncology Trials team, recruitment plans and strategy, informed consent forms, and clinical metrics reports. You will assist the Research Co-ordinators and Senior Research Coordinator 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 to ensure the team is conducting research in accordance with UK and/or EU regulation(s) and local guidance.
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 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 expert coordination support working collaboratively with the lead consultants and lead research nurses.
Main duties of the job
To establish and maintain effective working relationships with staff members both within Haematology/Oncology research team and directorate, CRF, other departments in the Trust and with relevant study centres.
• Liaise with members of the relevant staff in Haem/Onc service and members of the laboratory team for the appropriate collection and delivery of samples for study patients.
• To inform and educate ward staff of specific clinical trials data management requirements, training staff if needed in the completion of Case Report Forms (CRFs) and accessing and entering data into electronic Case Report Forms (eCRFs) promoting good clinical practice
• Responsible for providing support to the Study / Clinical teams during set-up, maintenance and close-out of clinical studies.
• Document management; assist in uploading CVs, GCP certificates, recruitment upload, monitoring reports on QPulse and Edge.
• Ensure Tracking databases are up to date along with entering study information into databases where appropriate.
• Support the Senior Research Coordinator Research Coordinators in administrative tasks.
• Arrange, attend and record minutes for specialty research meetings and other relevant departmental meetings where necessary.
• Assist in the maintenance of Study files, by ensuring these are kept tidy and updated.
• Organise, attend, and minute meetings or training events relevant to the start-up, conduct or closure of studies.
Working for our organisation
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.
Detailed job description and main 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 criteria
* 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 ( science, health, health management, social science)
Culture and Values
Essential criteria
* Our Always values •Always welcoming •Always helpful •Always expert •Always one team
* Experience of working as part of a diverse team.
Experience/Knowledge
Essential criteria
* Experience of working on multiple parallel tasks to strict and often tight deadlines
* Experience of managing information systems and developing databases and spreadsheets
* Knowledge of the Data Protection Act
* Relevant secretarial/administrative experience (ideally in a health care setting)
* Experience of setting up and managing filing systems
Desirable criteria
* Experience of clinical study/trial data administration
* Knowledge of web-based applications
* Understanding of NHS administrative processes
* Experience working in research environment
* Experience of working in a clinical trial environment in either a pharmaceutical company, NHS Trust or a university
Skills/Abilities
Essential criteria
* 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 work autonomously
* Able to make sound judgments, use own initiative and work with minimal day-to-day supervision
* Openness – Shares information and good practice appropriately
* Accountability – Takes responsibility for own actions, works effectively as a team member and promotes good team working
* Mutual respect – Treats others with courtesy and respect at all times
Desirable criteria
* A flexible approach to work and able to travel to attend meetings as required