Job responsibilities
Job Description: Clinical Trial Assistant
Job Title: Clinical Trial Assistant (CTA) Department: Thames Valley Hampshire Primary Care Commercial Research Delivery Centre
Reports to: Operations and Finance Lead, Primary Care Commercial Research Delivery Centre
Location: Windrush Medical Practice, Oxfordshire but travel to GPs surgeries within the TVH PC-CRDC required
Contract Type: Fixed-term to 31 October 2028
Hours: Full-time (part-time may be considered, minimum 4 days per week)
Occasional weekend working may be required
You may be asked to work flexible hours, depending on the needs of the trials portfolio, defined by the schedule of booked clinics and meetings
Salary: not Agenda for Change but band 3-4 equivalent
Key Responsibilities
Trial Administration
Provide administrative support for the set-up, conduct, and close-out of clinical trials.
Archiving and secure disposal of documentation as instructedMaintain study documentation, including Trial Master File (TMF) and Investigator Site File (ISF).
Prepare and track essential documents such as delegation logs, ethics approvals, and training records.
Assist in scheduling and organising trial-related meetings, site visits, and monitoring activities.
Creation and monitoring of communications with participants including email and other messaging platforms e.g. Docmail, AccuRx
Monitoring and responding to enquiries arising from emails, telephone or other contacts in liaison with other members of the trials teams
Ensuring the working environment is kept tidy and accessible for research colleagues and practice users
Arranging, monitoring and organising team members to meet courier collections/deliveries bookings e.g. dispatch and receipt of samples and dry ice deliveries
Reception and Non-clinical Duties During Clinics
Provide a friendly welcome to participants on arrival at clinic
Check documentation and non-clinical processes are completed as instructed
Maintain a tidy, organised clinic environment to ensure items are easily located and appropriately stored
Liaise with research clinicians to ensure the smooth running of the clinic
Data and Documentation
Support data collection, data entry (electronic and paper based systems), and verification in accordance with study protocols.
Filing and retrieval of documents within record storage systems
Use of photocopier to produce paper and scanned copies of documentation
Ensure accurate maintenance of participant screening and enrolment logs.
Assist in the preparation and submission of regulatory and ethics documentation.
Maintain version control of trial documents and ensure appropriate filing in accordance with SOPs.
Sample and Logistics Management
Support the coordination of biological sample collection, processing, and shipment (organise the schedules for collection, transport and receipt of samples
Track receipt and storage of trial materials, kits, and supplies.
Monitor stock levels and ordering equipment and supplies as delegated
Participate in the ordering and receipt of transport medium e.g. dry ice and the recording and packing of samples for shipping off site.
Maintain laboratory and other records to track samples and results.
Following SOPs and Laboratory Manuals, record, process and store samples (e.g. nasal swabs, saliva and blood) to ensure adherence to trial requirements.
Take action where samples are not received, processed, transported or reported as expected.
Quality and Compliance
Undertake required study specific training including relevant Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP)
Ensure compliance with SOPs, GCP, GDPR, and local governance requirements.
Participate in audits, monitoring visits, and inspections as required.
Maintain confidentiality and data protection standards at all times.
Communication and Support
Liaise with investigators, clinical teams, and sponsors to provide timely trial updates.
Contribute to meeting agendas, minutes, and progress reports.
Attend meetings
Assist in training new research support staff or students as appropriate.
Liaise with members of the wider trials team, participants, practice staff and other wider PC-CRDC colleagues and other stakeholders
CONFIDENTIALITY
The post holder may have access to confidential information relating to patients, their carers, practice staff and other healthcare workers. They may also have access to information relating to the PC-CRDC as a business organisation. All such information from any source is to be regarded as strictly confidential.
Information relating to patients, carers, colleagues, other healthcare workers or the business of the PC-CRDC may only be divulged to authorised persons in accordance with the organisation policies and procedures relating to confidentiality and the protection of personal and sensitive data.
HEALTH & SAFETY
The post holder will assist in promoting and maintaining their own and others health, safety and security as defined in the Health & Safety Policy.
EQUALITY AND DIVERSITY
The post holder will support the equality, diversity and rights of patients, carers and colleagues to include:
acting in a way that recognises the importance of peoples rights, interpreting them in a way that is consistent with the practice procedures and policies and current legislation.
Respecting the privacy, dignity, needs and beliefs of patients, carers and colleagues.
