Back to search
Trust:Â Royal Devon University Healthcare NHS Foundation Trust
Location: Exeter, Wonford, EX2 5DW
Job Purpose:Â
The post holder will work as part of the clinical research team to support the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.
The post-holder will work with the research team to provide administrative, clerical and data management support for all aspects of research study delivery across an extensive portfolio of clinical trials.
Key Result Areas/ Principal Duties and Responsibilities:
Research and GovernanceÂ
• Assist the clinical research team in coordinating a portfolio of National Institute Health Research  (NIHR) studies.
• Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
• Assist in study set up processes:
• Expression of interest & study selection documents
• Liaise with the study sponsor, R&D facilitator team, relevant support and research teams to  assist in the successful set up of new studies
• Prepare submissions for local research and development approval
• Coordinate site initiation meetings
• Set up the local site file & collate documents
• Ensure EDGE is correctly set up & data correctly maintained throughout the study
Take a leading role in on-going study coordination including:
• Conduct regular site file maintenance to ensure study essential documents are version controlled and maintained according to regulatory requirements
• Maintain effective communication between the study sponsor and the clinical research team
• Support local implementation of study amendments
• Update quality systems to record study information and enrolled patients details
• Coordinate and prepare documents for patient visits
• Respond to patients/carers telephone calls tactfully and professionally
• Book trial specific investigations and procedures
• Coordinate study monitoring visits
• Assist with data queries and AE / SAE reporting
 Take a leading role in study close out procedures including:
• Liaise with the sponsor for final monitoring visit
• Preparing study documents for archiving
• Liaise with R&D and following archiving SOP & procedures
• Assist with data entry according to study complexity and ensure that data is transcribed accurately where required.
• Support internal audit and monitoring.
Service Delivery and Improvement:
• Take a leading role in providing all aspects of general administration and clerical work for theÂ
clinical research team including but not exclusively:
• Document preparation
• Book couriers & coordinate sample collections
• Taking phone calls
• Book Appointments
• Email and fax correspondence
• Typing letters
• Maintaining databases, shared drives, generic email boxes and calendars
• Filing
• Patient records requests and collection
• Gaining signatures
• Office management (including electronic calendar / diary management
The post holder is required to deal effectively with staff of all levels throughout the Trust as and whenÂ
they encounter on a day to day basis
System Knowledge:Â
Use of Word/Excel to populate documents, send letters. Answer phone calls, collect signed documents, desire to complete training such as GCP (M) Inputting into databases/EPIC (D)
Knowledge/Skills:
Excellent Organisational Skills
Planning/Organisational Skills
Analytical / Jugemental Skills
Communication/ Relationship Skills
Research and Development
Working knowledge of Microsoft office packages (spreadsheets, databases,Â
word processing and e-mail)
Ability to communicate with staff and patients
Ability to prioritise workload to respond to changing demandsÂ
Excellent telephone manner and written communicationÂ
Understanding of National Institute for Health Research Clinical Research Network
Understanding of the clinical research process including Good Clinical Practice
Physical Skills:
The post holder will be required to use their IT skills including MS Office, Google docs, internet, databases etc. in order to monitor activity, systems and processes and to produce reportsÂ
including in time-bound circumstances.
• Standard/good keyboard skills are required for the inputting and manipulating of data and/or information on computer databases.
Experience :
Substantial administrative or clerical experienceÂ
Previous employment within a healthcare settingÂ
Clinical Research experience
Data management experience
Personal Attributes :
Enthusiastic, motivated and committed to developing a professional service
Flexible approach to work and the needs of the service
Able to prioritise and use own initiative
Remain calm in difficult situations
Proven ability to work as part of a multi-disciplinary team
Excellent communication skills; confidentiality, tact and diplomacy
Other Requirements :
Ability and willingness to work across multiple sites
The post holder must demonstrate a positive commitment to uphold diversity and equality policies approved by the Trust.
Committed to further professional development
** Applicants are given a short word and excel test within time slot during interview. **
