Job responsibilities
Job Summary:
To work as a member of the R&D team to assist in the delivery of quality care and service to research participants and researchers within a dedicated research setting. Working closely with Research Nurses, Principal Investigators and clinical teams providing sound accurate clinical research data for participants taking part in clinical research /medicine trials.
Key Duties/Responsibilities
Communication & Relationships Skills
The post holder will:
- Liaise with all members of the multidisciplinary team to ensure the smooth and efficient running of trials;
- Support data inputting and ensure all data is entered in a timely manner within 48hours of a participant visit occurring;
Provide and receive routine information including complex or sensitive information relating to participants or their legal representative. This may include completion of face-to-face questionnaires with participants in accordance with protocols.
Work in conjunction with research staff to prepare relevant information to ensure source data is collected at appropriate times according to the trial protocol.
Work with the research team to prepare and review study documentation in preparation for Audit and Regulatory Inspection.
Develop and maintain effective communication and working relationships within the service, the Directorate and Trust.
Support and organise monitoring visits, site qualification and site initiation visits
Ensure all members of the team as appropriate are included in arrangements for monitoring and site qualification and site initiation visits
Organise regular research team meetings, both internal to the Research and Development department and for the specialty area.
Knowledge, Training & Experience
The post holder will have:
- Knowledge and experience of using web based data handling software.
Knowledge and experience of working with data spread sheets.
Knowledge and experience in the preparation of clinics prior to research participants visits according to the study protocol.
Knowledge and experience of general office administrative duties e.g. filing, photocopying, scanning and faxing trial documents in line with patient confidentiality regulations.
Training and experience in performing all research activities according to ICH/GCP standards.
Acquire additional clinical trial data from hospital computer systems, GPs, external hospitals and organisations in compliance with information governance.
The ability to multi-task and prioritise a varied workload.
Knowledge and experience in providing accurate reports collating, validating and reporting participant activity to support medical and nursing staff enquires.
Maintain patient and research confidentiality
Knowledge of valid informed consent process in clinical research and retrospective consent
Minute taking skills to minute meetings internal and external to R&D
Analytical & Judgemental Skills
The post holder will:
- Be responsible for the maintenance of essential documents within the Investigator Site Files
- Be responsible for preparing essential documentation for archiving
- Be able to provide analysis and advice for all ad-hoc requests for data within the department.
Be able to make and receive telephone calls, handle enquires competently and sensitively which relate to research participants; take clear messages, recognise urgencies and pass the messages on appropriately.
Responsibility for ensuring all documents to be reviewed and monitoring visits are sourced and available for review.
Proactively identify potential participants for study inclusion and highlight to research staff/R&D team.
Assist the Research Team in the formulation of documentation in preparation for ethical submission.
- Assist in the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.
Planning & Organisational Skills
The post holder will:
- Organise research staff to be available when monitoring visits are scheduled and arrange time with the monitors.
- Be able to work efficiently with other members of the team to ensure the smooth running of the Research Team. To communicate any problems to the relevant individual
- Be able to organise copies of materials and collation of information as requested by the Research Team.
- Be able to liaise with research staff and arrange participant appointments according to protocol.
- Be able to maintain a monthly accrual list of participants to all studies and distribute among relevant members and departments, including the R&D Directorate and the National Institute for Health Research.
- Be responsible for booking and confirming availability for monitoring visits including the organisation of adequate space.
- Attend Site Initiation visits.
- Attend Investigator meetings, nationally.
- Monitor and log study and team telephone calls
- Collate activity and other information in order to support research, audit and other projects, as required by the Research Team and other clinical colleagues.
- Maintain stock supplies of information provided to participants.
- Assist in fulfilling other ad-hoc duties as required by the Research Team.
- To maintain Site Files for Commercial studies and Non-commercial as delegated.
Physical Skills
The post holder will:
- Standard keyboard skills to input patient data onto relevant databases
- Maintaining various research data bases within research.
- Ensure that all research study materials are up to date and in date.
Responsibility for Patient/Client Care
The post holder will:
- Assist with non-invasive research activities, e.g. questionnaires.
- Ensure that all participants details are kept up to date and any anomalies rectified.
- Organise the co-ordination of research participant activity.
- Provide participants with Participant Information Sheets relating to clinical trials.
- Identify and respond to participants needs, ensuring participants and visitors are always received courteously and assisted accordingly and with consideration.
Responsibility for Policy/Service Development
The post holder will be required to:
- Comply with all Departmental and Trust Procedures and Policies.
Responsibility for Financial and Physical Resources
The post holder will:
Organise patient reimbursement for their participation in clinical trials. This includes travelling expenses and sustenance costs.
Be able to adapt to change within the Department/Directorate and within your own job role to benefit the service.
Maintain and ensure an adequate supply of stationery.
Responsibility for Human Resources
The post holder will:
- Undertake any further administrative and clerical duties as required by the Senior Clinical Support Administrator and the Clinical Team.
- Attend any Department/Directorate meetings as required.
- Take reasonable care for your own health and safety and that of any other person who may be affected by your actions or omissions at work.
- Co-operate with the Trust in ensuring that statutory regulations, codes of practice, local policies and departmental health and safety rules are adhered to.
Responsibility for Information Resources
The post holder will:
- Be responsible for collecting and entering data, requesting receiving and processing tests and clinical results as required.
- Operate and maintain effective filing and support systems.
- Be responsible for maintaining up to date and accurate databases required by the Research Team/Department.
- Assist in data collection and entry for studies onto the EDGE database.
Responsibility for Research and Development
The post holder will be required to:
- Undertake study specific training as necessary
- Maintain knowledge, training and experience in clinical research and clinical trials. It will be the post holders responsibility to ensure the smooth running of the research clinics.
- Ensure that all trial staff meet Good Clinical Practice (GCP) training requirements and have in date research CVs
- Attend regular Research and Research Network meetings to ensure that Research Services continue to improve and develop.
- Attend Investigators meetings for clinical research trials if required.
- Assist colleagues where possible to develop professional competence.
- Cross cover for colleagues when needed in agreement with the Senior Clinical Support Administrator/ Lead Nurse.
Freedom to Act
The post holder will:
- Operate mainly on their own initiative, but will refer more complex issues to senior members of staff
- Be responsible for their own day to day work load, planning duties, etc..
- Be expected to use their initiative and work independently within the guidelines.
Physical Effort
The post holder will be required to:
- Attend meetings at various locations.
- Attend clinics as required including delivery and collection of prescriptions/blood samples as and when required
- Frequently input data onto the EDGE database and trial databases
Mental Effort
The post holder will:
- Have frequent requirement for prolonged concentration for inputting data, required accuracy and constant checking.
- Have a good team working philosophy.
Emotional Effort
- Exposure to distressing or emotional circumstances is rare
Working Conditions
The post holder will:
- Be required to work at several locations within the Trust.
- Be required to regularly use a computer.
