Job Description and Person Specification (HR5) /
Job Description
School/Department: / Faculty of Medicine, Cancer Sciences Division, Clinical Trials Unit
Post Title: / Quality and Regulatory Officer
Please enter Level under appropriate Career Pathway / ERE / TAE / MSA / CAO / R.Nurse / Clinical
3
ERE Category / Academic Posts / Non-Academic Posts
Academic
(mixed) / Research
only / Teaching
only / Enterprise / Education Development
Posts Responsible to (and Level): / Quality and Regulatory Manager
Posts Responsible for (and Level): / Supervision of the activities performed by the Quality and Regulatory Assistant
Job Purpose:
The Southampton Clinical Trial Unit (SCTU)designs, initiates, conducts and analyses high quality national and international clinical trials to directly influence routine clinical practice. SCTU has been awarded full registration with the UK Clinical Research Collaboration and has established quality and regulatory systems to ensure that trials are conducted to the highest standards.
The Officer will assist the Quality and Regulatory Manager in theadministration of pharmacovigilance, legal contracts and quality management activities associated with trials being managed by the SCTU. They will report directly to the Quality and Regulatory Manager and be expected to act as the first contact for the Quality and Regulatory Department. They are responsible for the supervision of the Quality and Regulatory Assistant in their day-to-day duties.Work will include liaison with research teams, providing advice and guidance on frequently asked questions relating to pharmacovigilance and contractual problems. TheOfficer willbe responsible forchecking and maintaining relevant up-to-date regulatory guidance andsupporting further development of thequality managementsystem.
Key Accountabilities/Primary Responsibilities:
Regulatory
Pharmacovigilance
  • To use checklists to prioritise all incoming safety reports from external NHS trusts and organise resolution of identified issues and queries with hospital staff via email or telephone.
  • To ensure that the reports are checked in a timely manner by a second medic.
  • To perform quality controlof safety report data to ensure that it is logged and tracked appropriately using excel and specific trial databases
  • Refer any identified Suspected Unexpected Serious Adverse Reaction reports to external authorities within regulatory timelines.To generate follow-up report requests as required, monitoring their completion and return from external research teams.
  • To produce and circulate regular safety event reports, from pharmacovigilance records, to external Sponsors, Funders and Agencies identifying and highlighting any key issues of concern under the direction of the manager.
  • To advise and assist all SCTU staff with pharmacovigilance training and queries, acting as the first contact point for routine issues.
  • To plan, prioritise and conduct safety event audits to fit with general schedules detailed by theQuality & Regulatory Manager.
Contracts
  • To prepare standard template trial contracts (clinical trial agreements),afterliaison with SCTU Clinical Trials Managers, taking into account trial budgets for completion of financial schedules.
  • Liaise with NHS Trusts’ legal and R&D departments regarding sign off of clinical trial agreements, referring any non-standard or clause-related problems to the Quality and Regulatory Manager.
  • To monitor the sign off process of clinical trial agreements by all external parties,responding to, and ensuring timely resolution of any agreement queries or problems by reference to the Manager when necessary.
  • Assist the manager with the set up of systems for monitoring invoices and reciprocal payments made to participating sites in relation to those agreed in the clinical trial agreements.
Quality Management
  • To take into consideration new external clinical trials’ guidance documents, regulations and EU directives, highlighting and prioritising any issues in the day-to-day quality and regulatory activities to support decision making by senior SCTU management.
  • To update standard operating procedures (SOP), working practice documents and files as required and approved by management via change requests.
  • To assist in developing and delivering training modules, relating to the SCTU quality system and new or updated SOPs for all SCTU staff, including induction packages.
  • To maintain records and provide reports of all staff training relating to quality management within SCTU to satisfy external audit requirements.
  • With the manager to plan and prioritise further development ofquality management procedures within the SCTU.
  • ToensureSCTU practice adheres to procedures byundertaking regular audits under the direction of the Quality and Regulatory Manager.
General
  • Provide general support to the Quality and Regulatory Manager: managing diary, arranging and attending, when required, internal and external meetings, collating and providing written information and documentation, as required.
  • To generate reports from spreadsheets and databases as requested, and to participate in relevant trial specific and SCTU meetings.
  • Managetraining and induction resources by monitoring use and status of equipment, identifying requirements, sourcing and obtaining additional resources as agreed by the manager.
  • To assist the Quality and Regulatory Manager in planningthe expansion of the department and improvingadministrative efficiency of both the department and the wider SCTU.
  • Any other duties appropriate to the band assigned by the Quality and Regulatory Manager.
The post holder will be expected to take a reasonable degree of responsibility for planning and managing their own workload and the supervision of the workload of the Quality and Regulatory Assistant.
The post holder will receive appropriate induction training into the business of SCTU and practices prevalent within the Quality and Regulatory team; however, they must have the necessary underpinning skills and attitudes to be able to carry out the work, as detailed in the personal specification. / % Time
50
35
15
Internal & External Relationships: (nature & purpose of relationships)
  • Other staff within SCTU
  • University of Southampton and University Hospital Southampton NHS Foundation Trustto promote good working relationships.
  • National NHS Trusts to secure and follow-up legal agreements and safety reports.
  • Medicines and Healthcare Products Regulatory Agency (MHRA) and Regional Research Ethics Committees – regulatory reporting within legal timeframes.
  • Trial specific groups with external members (Management groups, Trial Steering Committees, Data Monitoring and Ethics Committees) to provide safety reports.
  • Staff at participating sites, to secure and follow up agreements and safety reports.
  • Funding bodies e.g. Drug companies – contract and safety information.
  • Internal and External Chief Investigators (consultants) – safety reporting.

Special Requirements:
The Quality and Regulatory Officer will be based at SouthamptonGeneralHospital within the established UoSCTU.
Person Specification
Criteria / Essential / Desirable / How to be assessed
Qualifications, Knowledge and Experience: / A Level,HNC,NVQ 3 or equivalent and proven work experience
IT Literate to GCSE level (or equivalent)
Knowledge of medical terminology
Knowledge and experience of designing and using spreadsheets and using computer databases (including logging and querying data)
Knowledge or experience of quality systems and audit
Previous experience in a busy office environment, with customer service experience / Degree or equivalent qualification and/or experience in a related role
A basic knowledge of the health service research community; possibly through working in or with the NHS
Knowledge or experience of medical research methodology, statutory clinical trial regulations, GCP and research governance requirements
IIA or ISO Auditor qualification / Application or interview
Planning and Organising: / Excellent attention to detail including high standards of accuracy
High degree of organisation
Ability to be flexible, proactive and use initiative
Capability to manage and prioritise a busy workload, sometimes under pressure
Ability to adapt and refine own work practices
Ability to work with established and evolving processes and procedures
Ability to plan and prioritise a range of one own’s and the team’s standard and non-standard work issues / Application or interview
Problem Solving and Initiative: / Ability to prioritise tasks
Able to identify and solve problems by applying initiative to tackle some situations in new ways and by developing improved work methods
The knowledge and ability to understand and rationalise problems, determine actions and follow good practice and standard procedures / Application and interview
Management and Teamwork: / Excellent interpersonal and communication skills, verbal, listening and written, with internal and external stakeholders
Able to work with and across teams in a busy office environment, share information and constructively support others
Able to motivate and oversee the work of others
Ability to liaise with individuals at all levels in different establishments / Application and interview
Communicating and Influencing: / Communicates effectively in both spoken and written English
Capacity to speak or train groups and individuals and explain processes clearly and concisely; and to write in a clear and factually/grammatically accurate way
Excellent telephone manner / Application and interview
Other Skills and Behaviours: / Personal drive and initiative
Capacity to manage time effectively and a commitment to working to high standards of accuracy
Proven ability to multi-task
Experience of working in a team and independently
Willing to attend courses to update or increase skills / Application and interview
Special Requirements: / Aptitude for, and interest in setting up systems / Application and interview

Job Hazard Analysis Form - Appendix to Job and Person Specification

Please tick one of the following statements:

This post is an office-based job with routine office hazards e.g. use of VDU (if ticked, no further information needs to be supplied) / √
This post has some hazards other than routine office e.g. more than use of VDU

Please tick all those that apply, and put N/A if not applicable

Environmental Exposures / O* / F / C
Outside work
Extremes of temperature (eg fridge/ furnace)
Potential for exposure to body fluids ##
Noise (greater than 80 dba - 8 hrs twa) ##
Exposure to hazardous substances (eg solvents, liquids, dust, fumes, biohazards). Specify …………………………………………………………. ##
Frequent hand washing
Ionising radiation.
Equipment/Tools/Machines used
Food Handling ##
Driving university vehicles(e.g. car/van/LGV/PCV) ##
Use of latex gloves (note: prohibited unless specific clinical necessity) ##
Vibrating tools ( e.g. strimmers, hammer drill, lawnmowers) ##
Physical Abilities
Load manual handling.
Repetitive Crouching/Kneeling/Stooping
Repetitive Pulling/Pushing
Repetitive Lifting
Standing for prolonged periods
Repetitive Climbing i.e. steps, stools, ladders
Fine motor grips (e.g. pipetting)
Gross motor grips
Repetitive reaching below shoulder height
Repetitive reaching at shoulder height
Repetitive reaching above shoulder height
Psychosocial Issues
Face to face contact with public
Lone working
Shift work/night work/on call duties ##

O – Occasionally (up to 1/3 of time); F – Frequently (up to 2/3 of time); C – Constantly (more than 2/3 of time) ## denotes to HR the need for a full PEHQ to be sent to all applicants for this position.

FOR SCHOOL/SERVICE USE ONLY / ResourceLink Post Number
Which post does this job report to
Is this post a Line Manager? / Yes / No
If yes, which posts directly report into it? / ResourceLink Post Number
Post 1
Post 2
Post 3
Post 4
Post 5
Post 6
Post 7
Post 8
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