£20330 - £21777 Per year
Assistant
Full Time
Job Description
- Provide general administrative support to the Trust’s team as directed, including the use of computerized systems (i.e. spreadsheets, databases, Microsoft Office).
- Work closely with the office, clinical colleagues, Clinical Research Network and other external parties.
- Support with some aspects of administration, including day-to-day delivery (i.e. follow-up aligned with Protocol requirements or where sponsor defines) and closure/ archiving of clinical research studies under the supervision of the Coordinator and Clinical Research Nurse team.
- Assist representatives from sponsor organizations, regulatory authorities and/ or the Office with trial monitoring visits, audit and inspection as required.
- Attend relevant internal and external meetings/ training sessions to develop research knowledge.
- Demonstrate professional and appropriate behaviour when dealing with internal and external enquiries, in adherence with the Data Protection Act and information governance. This includes verbal and other communication methods as appropriate to the situation.
- Liaise with internal and external staff regarding case notes, data collection, biological samples, mortality data and other general trial activities, which may be confidential in nature.
- Attend and contribute to clinical research team meetings, network events and sponsor-led meetings.
- Assist with preparation of reports and presentations for the team as required.
- Demonstrate flexibility, enthusiasm and motivation in daily practice.
- Support Clinical Research Nursing staff and Clinicians to maintain clear and accurate clinical trial record (including processing of study amendments and safety reporting).
- Ensure all research participants are dealt with in a courteous and sensitive manner when contacted to assist with study data requirements, questionnaire completion or when in attendance at study visits including reception duties.
- Assist patients/ service users/ careers/ relatives during incidental contacts.
- Liaison with internal service departments (i.e. pathology, pharmacy, radiology) as appropriate.
- Schedule and organize internal/ external meetings, including room bookings, catering orders, agenda preparation/ circulation, attendance coordination and minute-taking/ distribution.
- Assist the Clinical Research Nursing staff with, preparation and follow-up actions for study visits (aligned with protocol requirements), multi-disciplinary team meetings, study monitoring and audit.
- Maintain electronic trackers for all aspects of research administration (e.g. participant screening, visit logs, work allocation, study lists, recruitment accruals) to support the smooth running and closure of research studies and internal/ external reporting requirements.
- Organize and plan own day to day workload or activities in order to meet the demands of the job role, communicating any resource issues appropriately.
- Provide administrative support for study-specific invoicing (including travel expenses).
- Ensure office supplies are adequate, ordered and obtained for the smooth running of the research team.
- Ensure safe and efficient use of equipment, resources and consumables at all times.
- To be aware of, comment on and actively participate in changes on policies, procedures or service developments.
- To embrace and support line management and the department in making service improvements effective within the workplace.
- Responsibilities for Human Resources and Leadership• Actively participate in activities to raise the Trust’s profile for research.
- To support new or less experienced work colleagues to adapt to the workplace.
- Participate in training and development activities that are relevant to the job role, sharing learning outcomes with the wider team as appropriate.
- Maintain accurate, up to date paper and electronic records of research performance and activity in accordance with the Data Protection Act, General Data Protection Regulation and GCP standards.
- Ensure appropriate records are available for research/ monitoring visits and audit.
- Understand the implications of the Data Protection Act, General Data Protection Regulation, Caldicott Guidelines and information governance to maintain research participant confidentiality.
- Ensure all clinical research administration activities are undertaken to ICH-GCP/ EU directives/ governance framework standards and in adherence with health and safety policies, reporting any incidents in line with Trust reporting processes.
- Liaise with study Clinicians, Clinical Research Nurses and other allied healthcare professionals to obtain documentation on contact details, qualifications, CVs, GCP evidence and other relevant documentation for study use.
- Ensure essential research documents are filed appropriately to maintain a robust audit trail for governance and regulatory inspection purposes.
- Store materials correctly and keep them in good condition.
- Use/ develop archive management tools to date, catalogue and index study materials in line with Sponsor requirements and current legislation.
- Make records available to users in formats such as photocopies and online.
Required Knowledge, Skills, and Abilities
- Demonstrate a good level of IT/ keyboard skills to support with the data collection/ activity reporting requirements specific to clinical research studies (including use of various electronic Trust, Clinical Research Network and case report form packages).
- Frequent concentration when using the computer.
- Safely use clinical equipment to carry out the job role.
- Physical effort to carry out the demands of the job role.
Reference no: 94643