Clinical Trials Assistant

Worcestershire Acute Hospitals NHS Trust; West Midlands Combined Authority; On-site; GBP 20,000 - 30,000; Full time

Job summary

A healthcare organization in the UK is seeking a Clinical Trials Assistant to support clinical research by identifying, recruiting, and managing research participants. The role includes assisting with data collection, conducting clinical procedures, and ensuring regulatory compliance. Candidates should have experience in clinical research and strong communication skills. This position offers opportunity for professional training and career development.

Qualifications

• Experience in clinical research settings desirable.
• Knowledge of Good Clinical Practice (GCP) guidelines.
• Ability to communicate sensitive information and build rapport with patients.

Responsibilities

• Screen trust systems to identify eligible patients for research studies.
• Obtain consent from patients for research participation.
• Organise appointments and perform clinical procedures as needed.

Job description

Key Working Relationships

Internal: Departmental colleagues, Lead Research Nurse, Head of Research Operations, Research Management Team, Research Delivery Teams, Clinical Teams, Support Departments

External: Patients and their relatives/carers/significant others, Research Sponsor Organisations, Clinical Trials Units / Universities, Pharmaceutical companies / Contract Research Organisations, NIHR Research Delivery Network, Herefordshire and Worcestershire Research Consortium Partner Organisations, Other External Research Teams

Risk Assessment

• Manual handling activities
• Exposure to bodily fluids and high noise levels
• Potential exposure to challenging behaviour
• Works with display screen equipment for prolonged periods

Job Purpose

We are committed to supporting research that is relevant and accessible to our patients. Through clinical research, we assess the efficacy of new medication, diagnostics, and treatments, building evidence to improve patient care. The Clinical Trials Assistant supports the Research Delivery Team in identifying, recruiting, and managing research participants, assisting with data collection, clinical and laboratory tasks, and administrative duties.

Key Duties

1. Screen trust systems to identify eligible patients for research studies
2. Obtain consent from patients for research participation, following GCP guidelines
3. Randomise patients into trial arms
4. Organise appointments and investigations
5. Perform clinical procedures such as blood pressure, heart and respiratory rates, and sample collection
6. Report findings and document in patient records and research files
7. Assess participant conditions and liaise with clinicians as needed
8. Process research samples according to protocols
9. Coordinate trial medication with pharmacy
10. Distribute questionnaires and surveys
11. Communicate sensitive information appropriately
12. Report adverse events
13. Assist with feasibility assessments and administrative duties
14. Maintain study documentation and ensure regulatory compliance
15. Set up and maintain study files and tracking systems
16. Participate in audits and monitoring visits
17. Ensure data accuracy and resolve queries
18. Attend meetings and maintain communication with stakeholders
19. Perform general administrative duties and maintain supplies
20. Coordinate amendments and liaise with trial units and sponsors
21. Maintain financial and patient records
22. Travel between sites as required
23. Participate in training and development programs

Training and Education

Includes Trust Induction, CREATE training, healthcare research MOOC, clinical skills, GCP, data quality, informed consent, site file management, CRF completion, EDGE, amendments, archiving, iPROC, and performance reviews.

General Duties

Cover other team members, liaise with departments for equipment maintenance, and undertake any other duties as appropriate.