Clinical Trials Administrator

The Research & Innovation (R&I) Department has responsibility for all elements of research governance within the Trust and provides corporate support to internal staff and external partners undertaking research and innovation projects.
The post holder will provide comprehensive administrative support to the clinical staff involved in the delivery of Clinical trials according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
Duties will include investigator site file maintenance, processing case report forms, assisting in the set-up of new trials and ongoing administrative management of existing trials within the department. The role requires the post holder to be self-driven, highly organised, have good communication skills and can work as part of a team.
Supporting the R&I team with all aspects of Clinical Trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
Maintain local records for all trials, including the set-up and maintenance of investigator site files (ISF), through to appropriate archiving.
Help facilitate the achievement of timeline targets in trial set-up, including the management of R-PEAK related administrative tasks.
Ensure version control of all essential documents, including the appropriate and timely dissemination of these to study leads.
Assist in monitoring levels of patient recruitment by recording screening and recruitment to trials and providing this data to the Clinical Research Officer.
Processing of Case Reporting Forms (CRFs) and securely sending to
Sponsors as required by agreed methods.
Processing of consent forms and other paperwork as required, including uploading research related materials to participants electronic patient record i.e., PARIS.
Manage the Participant in Research Experience Survey (PRES) within the department, including inviting research participants to participate via letter or telephone.
Print research related materials i.e., recruitment packs, promotional materials, for research staff within the department.
There are few careers as rewarding as those in the NHS, or that give you the opportunity to work with such a variety of people.
At Pennine Care, we actively recruit people of all ages, backgrounds and levels of experience as this helps us understand the different needs of our patients and provide the best possible service.
We are committed to being a great place to work which means we place a great deal of importance on the experience of our staff. We are committed to:
Effective recruitment and retention of our staff
Developing new roles and ways of working to ensure a flexible and innovative approach to staffing
Equality of opportunity and having a workforce that represents the communities we serve
Continual training, development and learning for all staff
Achieving a work-life balance and creating positive staff experiences which support wellbeing
Offer a great working environment and an attractive range of benefits.
Research:

• Supporting the R&I team with all aspects of Clinical Trials administration,

according to Good Clinical Practice (GCP), standard operating procedures
(SOPs) and Trust policies.

• Maintain local records for all trials, including the set-up and maintenance ofsite files, through to appropriate archiving.
• Help facilitate the achievement of timeline targets in trial set-up, including the management of R-PEAK related administrative tasks.
• Ensure version control of all essential documents, including the appropriate and timely dissemination of these to study leads.
• Liaise between site staff of all levels and Sponsors to arrange site initiation and monitoring visits.
• Assist clinical trial monitors in site visits, arranging space and access to

appropriate files and systems.

• Build and maintain good working relationships with colleagues, R&I staff,

clinical departments and all research partners.

• Assist in monitoring levels of patient recruitment by recording screening and recruitment to trials and providing this data to the Clinical Research Officer.
• Processing of Case Reporting Forms (CRFs) and securely sending to

Sponsors as required by agreed methods.

• Processing of consent forms and other paperwork as required, including

uploading research related materials to participants electronic patient record i.e., PARIS.

• Manage the Participant in Research Experience Survey (PRES) within the

department, including inviting research participants to participate via letter or telephone.

• Print research related materials i.e., recruitment packs, promotional materials, for research staff within the department.
• Maintain study related folders electronically within the department.
• Input research related data into database management software when

required i.e., REDCap.

• Prioritise and manage data queries to resolution in a timely manner.
• Maintain effective filing systems, including Excel spreadsheets and other

electronic documents.

• Ensure accurate R&I information is on research documentation i.e.,

Participant Information Sheets in advance of printing.

• Attend training relevant to the Clinical Trials Administration role, including Sponsor specific training.

Clinical:

• Ensure a system is in place to track protocol trial visits and enable data

collection points to be met.

• Use judgement when processing case report forms (CRFs) and data queries -complete where appropriate and refer to the research practitioner / study lead as required.
• Ensure that patient concerns are dealt with sensitively and confidentially,

referring them to the appropriate member of the clinical team as necessary.

• Send out appropriate correspondence to patients such as invitations to

participate in research.

• Type up and post out study related letters to participants, GPs, and other

contacts, as required.

• Liaise with GPs to gather any clinical information required for the participation in research.

Leadership and Management:

• Manage lone working within the department of research delivery staff

undertaking home visits.

• Maintain the R&I Department’s intranet page, ensuring that all current

research studies are advertised, and the information is accurate.

• Communicate clearly with colleagues, keeping the team updated on things

such as trial management workload, monitoring visits, and passing on
messages and emails appropriately.

• Lead on the day-to-day trail administration for the team, flagging any issues or barriers to this with the Clinical Research Officer.
• Manage trial supplies, including venepuncture materials, requesting more

before they run out.

• Ensure that office supplies are adequate, ordered and obtained for the

smooth running of the office.

• Help train appropriate staff on the use of any local trial administration

processes, systems, or IT packages.

• Attend, contribute, and take minutes for all department related meetings held internally and externally.
• Answer telephone calls within the department and take accurate messages for colleagues in a timely manner.
• Assist the research delivery team with any additional administrative tasks as required.
• The post holder is expected to be able to prioritise assigned tasks and act on own initiative.

Education:

• Keep up to date with all mandatory training, both for Trust and research

requirements, and help identify activities towards your own professional
development.

• Maintain research relevant training records for the department, such as Good Clinical Practice certificates and Research CVs, and request updated versions when required.
• Share knowledge with the team and help them with any required training in trial administration.

Professional:

• Adhere to all relevant legislation, policies, SOPs, and protocols including

confidentiality, data protection, information governance and research
governance.

• Monitor workload and prioritise accordingly, seeking assistance where

appropriate.

• Alert any inconsistencies or blank fields in completed CRFs and consent

forms before submitting or filing to the relevant research practitioner.

• Provide accurate data when requested for various performance reports.
• Assist with the preparation of presentations and reports.
• Be pro-active in monitoring working practices within research teams,

identifying best practice and suggesting any improvements to administration
processes.