Clinical Trials Assistant

Windrush Medical Practice; Witney; Hybrid; GBP 25,000 - 35,000; Full time

Job summary

A healthcare organization in England is seeking a Clinical Trial Assistant to provide essential administrative and operational support for commercial clinical research studies. The role includes tasks such as trial administration, data collection and logistics, as well as ensuring compliance with Good Clinical Practice standards. Candidates should have a degree in Life Sciences or a related field, experience in an administrative or research support role, and strong attention to detail. This is a full-time fixed-term position.

Qualifications

• Experience in administrative or research support role.
• Understanding of clinical trial processes.
• Good standard of general education, especially in English and numeracy.

Responsibilities

• Provide administrative support for the set-up and conduct of clinical trials.
• Assist trial staff in documentation and data entry.
• Support the coordination of biological sample collection.

Skills

Attention to detail

Organisational skills

Communication skills

Understanding of data protection

Knowledge of GCP

Education

Degree or diploma in Life Sciences or related field

Educated to A-level or equivalent

Tools

Microsoft Office

Database systems

Job description

The Clinical Trial Assistant (CTA) provides essential administrative and operational support to ensure the effective conduct of commercial clinical research studies as part of Thames Valley Hampshire Primary Care Commercial Research Delivery Centre (TVH PC-CRDC).

Main duties of the job

Working closely with trial staff and coordinators, investigators, and data management teams, the CTA assists with trial documentation, data entry, regulatory submissions, and sample or data logistics. This role is key to maintaining compliance with Good Clinical Practice (GCP), sponsor requirements, and organisational policies. This role will require some travel to GPs surgeries within the TVH PC-CRDC.

About us

Windrush MedicalPractice, Witney, Oxfordshire, has been awarded NIHR funding to establish the Thames Valley Hampshire (TVH) Primary Care Commercial Research Delivery Centre (PC-CRDC), covering the Oxfordshire, Berkshire and Hampshire region and is one of 14 GP-led primary care organisations funded across England to expand commercial research delivery and improve access to groundbreaking clinical trials.

The partnership includes Eynsham Medical Group and Banbury Cross Health Centre as well as collaborations with six practices across Oxfordshire, Berkshire and Hampshire region to provide cutting edge health research opportunities to all communities within the region. Collectively we serve >394,000 patients from a range of ethnic and socioeconomic backgrounds. Our vision is to make it simple and accessible for people to take part in high-quality health and care research at their GP practice. Our mission is to deliver health and care research studies that bring new treatments and innovations to primary care patients, while supporting the NHS and growing research capacity in our region.

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 instructed.
• Maintain 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.

Person Specification

Knowledge and Skills

• Attention to detail including ability to follow instructions.
• Strong organisational and time management skills.
• Competent in Microsoft Office and database systems.
• Understanding of confidentiality and data protection.
• Knowledge of GCP and regulatory requirements.
• Familiarity with electronic data capture.

Qualifications

• Educated to A-level or equivalent experience.
• Good standard of general education, particularly in English and numeracy.
• Degree or diploma in Life Sciences, Health, or related field.
• GCP certification.

Personal Attributes

• Able to adapt to a changing working environment.
• Reliable, adaptable, and able to prioritise workload effectively.
• Commitment to maintaining quality and compliance.
• Enthusiastic and motivated to develop within clinical research.

Experience

• Able to work on own initiative and as part of a team.
• Experience in administrative or research support role.
• Experience of working in a clinical trial environment.
• Experience of working with samples or other materials in laboratory or clinical setting.
• Understanding of clinical trial processes or research governance.
• Previous experience in a research, GP, NHS, or pharmaceutical environment.
• Experience maintaining study documentation (e.g., TMF).

Mobility and Travel Requirements

• Able to travel to multiple GP locations across the Thames Valley and Hampshire PC-CRDC.
• Access to vehicle and full clean drivers licence.

Communication and Teamwork

• Excellent written and verbal communication skills.
• Able to work collaboratively with multidisciplinary teams.
• Professional and proactive approach to problem-solving.
• Experience supporting multi-site or international trials.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Depending on experiencenot Agenda for Change but band 3-4 equivalent