Choose Well - Choose WWL
Job overview
We are looking for a Clinical Trials Administrator to join out team, working 21 hours per week! The main purpose of the role is to assist the clinical research delivery team with all aspects of administration in relation to research activities. To work efficiently and to a high quality according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
Close liaison is required between the Trust, Christie Hospital, Wigan and Leigh (WWL) Research and Development Team.
Although this role is offered at Band 3, there is potential for the successful candidate to progress to a Band 4 position after 12 months, on completion of the required competencies. Please note that this is subject to available funding, and service needs.
Main duties of the job
To provide administrative assistance with delivery of the research portfolio of projects in conjunction with study leads, senior investigators, Clinical Research Delivery Team staff and the Trust Research & Development team. (This would include administrative delivery of observational studies with no clinical interventions or medical interpretation requirements; and administrative support for those studies requiring medical interpretation led by the Clinical Research Nurses/AHPs, the Principal Investigator and Sponsor).
To provide administrative assistance to staff within and the Clinical Research Delivery Team for study management purposes across the department as required.
Working for our organisation
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust are the proud providers of acute hospital and community services to the people of the Wigan Borough and surrounding areas. At WWL, we value our staff believing that ‘happy staff, makes for happy patients’. We have a recognised track record in staff engagement, and living our values ‘the WWL Way’.
WWL are committed to placing the patient at the heart of everything we do, and in the provision of safe, effective care that acknowledges and ensures dignity. With this in mind we are seeking to recruit people who share our values and beliefs.
At WWL we value the benefits a rich and diverse workforce brings to our community and therefore welcome applications from all sections of society.
Detailed job description and main responsibilities
Duties and Responsibilities
The post holder will assist with the administration of research projects:
1. To provide administrative assistance with delivery of the research portfolio of projectsin conjunction with study leads, senior investigators, Clinical Research Delivery Teamstaff and the Trust Research & Development team. (This would includeadministrative delivery of observational studies with no clinical interventions ormedical interpretation requirements; and administrative support for those studiesrequiring medical interpretation led by the Clinical Research Nurses/AHPs, thePrincipal Investigator and Sponsor)
2. To provide administrative assistance to staff within and the Clinical Research Delivery Team for study management purposes across the department as require
Key results from the job holder
3. To provide efficient administrative assistance in the set-up of all studies within theClinical Research Delivery Team To maintain contact with pharmaceutical companies, study sponsor, clinical trials unit,clinical research associates, Research Office and Research Networks
4. To assist the studies team regarding Health Research Authority (HRA)/NHSResearch Ethics Service, the Medicine and Healthcare products Regulatory Agency(MHRA) and other regulatory submissions and funding arrangements.
5. To have a good understanding of HRA, MHRA and research network submissionprocesses to facilitate rapid study set-up.
6. To liaise with Research Governance team to achieve NHS Permissions and Trustapproval, along with any governance requirements for studie
Planning and Organisational Duties
7. To attend appropriate Study Training and adhere to Local Trust and national
guidelines and Policies.
8. To provide administrative assistance with trial documents such as schedules of
investigations, patient information sheets, consent forms, GP letters, data sheets,
case report forms and adverse event forms.
9. To carry out procedures in compliance with the principles of Good Clinical Practice,
the Research Governance Framework and all regulatory legislation.
10. In liaison with the research team administer procedures (such as study projection
data) ensuring that study specific investigations are carried our correctly and in a
timely manner; scheduling patient follow-up visits and assessments (including those
with other departments within the Trust or study requirements) to ensure protocol
compliance.
11. To ensure tissue and biomaterial handling, collection and storage is implemented
according to SOPs and liaise with the Trust’s HTA licence holder regarding collection,
storage and transfer of tissue samples when there are compliance queries.
12. To keep abreast of Trust-wide research SOPs and policies and notify the research
team of changes.
13. To ensure Study site/master files are always maintained and kept inspection ready.
14. To organise co-ordination and collection of case notes for all patients as needed for
screening, monitoring and audit.
15. To file appropriate information into case notes and ensure notes are returned in a
well-ordered condition.
16. Liaise with research team and co-ordinating centre staff to ensure data sent is valid.
17. Support clinical trial monitors in site visits, with accurate monitoring of data.
18. Exercise judgement when dealing with patient enquiries. Assess and manage query
if clerical, refer to the research nurses as required.
19. To liaise with study investigators and nurses to obtain documentation on contact
details, qualifications, CVs and other relevant documentation for study use.
20. To administer timely and efficient procedures for collection, electronic input and
verification of all patient data, chasing of missing or incomplete data and raising
queries as appropriate.
21. Ensure all study documentation is completed, maintained and updated regularly.
22. Enter clinical data transcribed from Case Report Forms (CRFs) on study websites as
instructed by Clinical Research Nurses in a timely manner.
23. Register study patients onto Trust system in a timely manner to facilitate R&D reports
and patient accrual data.
24. Collate information from the Trusts systems to aid the research team in managing
their research portfolio and performance.
25. To monitor data quality and maintain quality control procedures in day-to-day work.
26. To process and communicate amendments according to GCP and Trust SOPs.
27. To administer processes to support the clinical research nurse/Principal Investigator with adverse event reporting as the study protocol and regulations require.
28. To take part in study/team meetings and keep the team updated on current work.
29. Transcribe minutes of meetings or create databases/spreadsheets
30. To communicate with the Trust Research Office, sponsors, funders, pharmaceutical companies, internal and external study personnel and outside agencies in a professional manner maintaining an efficient flow of information to sustain smooth running of the study.
31. To administer archiving systems according to sponsor and Trust requirements and SOPs/policies, retrieving documents when required.
32. To perform site file management in preparation for audit internal and external.
33. Be proactive in monitoring working practices and suggesting improvements and new ways of working.
34. To provide administrative support to assist in monitoring performance within the Clinical Research Delivery team.
35. To work with the Research & Development team and Sponsorship Team to provide information for Trust-wide electronic information systems to track patient accrual, recruitment targets and speciality activity
Responsibility for Finance
Clinical Study Financial and Resource Administration
36. To provide administrative support for invoicing, travel expenses and other financial
transactions –including ordering supplies.
37. Ensure that office supplies are adequate, ordered and obtained for the smooth
running of the research team.
38. Arrange shipment of samples to external laboratories according to appropriate
regulations and policies.
39. To communicate any resource issues in administrative workload within the
department.
Communications and Key Working Relationship
40. Answering incoming calls in a polite and professional manner and takes appropriate
action as required e.g. takes messages, provides information or refers to relevant
person. To be prepared for occasional exposure to distressed circumstance as trial
patients are commonly suffering from long term, serious illness. Ability to troubleshoot
effectively when dealing with patient enquiries.
41. The post holder must be comfortable in communicating across all levels of staff
including dealing with nursing and administrative staff, management and consultants.
42. Liaise with internal departments, such as R&D, pharmacy, labs and radiology, to setup studies, collect data and notify of study closure.
43. Liaise with other Trusts, networks and external agencies regarding research studies.
44. Service team meetings including organising room bookings and catering, sending out
agendas, co-ordinating attendance and taking, producing and distributing minutes.
45. Ensure coordination and collection of clinical case notes for all patients are available
as needed, for screening, monitoring and audit
46. Communicate patient schedule with Clinical Delivery Team for patient visits to ensure
they are not overlooked and have fulfilled any study assessments according to study
protocol
Responsibility for Human Resources
47. To be able to plan and organise own time and workload activity with prioritisation.
48. To be able to work independently using own initiative.
49. To be a part of the whole Research Department and be involved in the development
of the Research Department in terms of its work programmes and progress.
50. To undertake further training related to the role as part of personal development and
due to a changing research environment.
51. To conduct any other duties as required by Line Manager that are commensurate
with the grade of post
Responsibility for Teaching
52. Assist in the induction process of new research team members.
53. Provide training to other clinical trial assistants.
Person specification
Qualifications
Essential criteria
54. GCSE/O LEVEL Maths and English or equivalent
55. Educated to at least NVQ3 or equivalent
Desirable criteria
56. Good Clinical Practice (GCP)
57. ECDL, CLAIT or equivalent qualification / experience
Experience
Essential criteria
58. Experience working within the health care system
59. Experience of office administration
Desirable criteria
60. Experience working within Clinical research/NHS
61. Experience of advanced administrative work including data management
Skills
Essential criteria
62. Advanced use of spreadsheet and other Microsoft Office Word, Excel, PowerPoint and other packages
63. Good oral and written communication skills
64. Good organisational abilities, with a methodical approach and the ability to pay attention to detail
Desirable criteria
65. Work with electronic Clinical Trial databases
Knowledge
Essential criteria
66. Knowledge of patient information systems
67. Knowledge of medical terminology
Desirable criteria
68. Knowledge of the clinical trials process
Additional
Essential criteria
69. Flexible with good time management
70. Ability to work to tight and/or unexpected deadlines
71. Speak English to an appropriate standard relevant to their role, i.e. with confidence and accuracy, using correct sentence structures and vocabulary, and without hesitation