Clinical Trials Research Support Specialist

Position Overview

South West London & St George's Mental Health NHS Trust is dedicated to conducting high-quality research. The Clinical Research Unit plays a vital role in managing a diverse research portfolio, focusing on observational and interventional Phase II-IV trials.

We are seeking a motivated Clinical Trials Research Support Specialist to join our team and assist with National Institute of Health Research (NIHR) Portfolio studies. This role offers an excellent opportunity for the successful candidate to gain hands-on experience in clinical research execution, collaborate with fellow researchers, recruit study participants, and perform clinical and psychometric evaluations. Opportunities for personal and professional growth through training, educational sessions, and career guidance will be provided.

Career Development and Opportunities:

We are committed to maximizing the potential of our staff and supporting their career goals. We offer clear career pathways that allow you to enhance your skills and gain experience to advance into various roles across different specialties. For this position, we provide pathways in Research & Development Governance and Clinical Research Execution.

Furthermore, we offer continuous training and development in R&D Governance, including the setup and management of clinical research.

Key Responsibilities

In this role, the candidate will be expected to:

• Recruit participants for NIHR clinical research studies and support the research delivery team across all areas of the Trust's NIHR research portfolio, which may involve working across multiple sites.

Flexible Working Arrangements:

As one of the few Trusts in London, we proudly offer flexible working arrangements as part of our innovative work practices. We are open to discussing flexible working options during the interview process. In this role, you will have the opportunity to work Monday to Friday between 08:00 and 18:00, promoting a healthy work-life balance.

About Us

At South West London and St George's Mental Health NHS Trust, we take pride in our commitment to providing high-quality care for individuals experiencing mental health challenges. Our services are rated as 'good' by the Care Quality Commission, and we strive to achieve 'outstanding' status.

This is an exciting time to join our organization as we transform the way we support our communities, aiming to make life better together. We have recently established two state-of-the-art mental health facilities, with further developments planned across our services.

We embrace inclusivity and diversity, actively seeking to attract individuals from all backgrounds to enrich our collaborative efforts. We are dedicated to co-producing and involving our local communities in all aspects of our work.

We provide flexible working options, career advancement opportunities, and a range of benefits to foster a positive and welcoming environment where our staff and their careers can flourish.

Core Responsibilities

• Develop a comprehensive understanding of the ethical principles governing clinical research and their implications for current practices.
• As a member of the R&D team, provide robust operational support in all facets of clinical trials administration, adhering to Good Clinical Practice (GCP) guidelines, local standard operating procedures (SOPs), and relevant Trust policies.
• Take responsibility for personal and professional development, ensuring that all relevant skills and training (GCP) are current to fulfill job-related responsibilities.
• Identify eligible mental health service users and carers for participation in various research projects, providing necessary information and support.
• Collect data through interviews, support, and monitoring of patients, collaborating closely with the Research Unit Coordinator and Data Analyst.
• Recruit patients for observational trials and assist in the completion of trial-specific documentation.
• Ensure that patient care, assessments, follow-ups, and data collection adhere to the appropriate research protocols, liaising with mental health, social care, and primary care services.

Clinical Responsibilities

• Prioritize the well-being of study participants in all research practices.
• Facilitate the recruitment of participants into clinical studies.
• Serve as a guide and advocate for patients during the decision-making process regarding trial participation.
• Utilize judgment skills to assess patient suitability for trial participation and communicate findings to their consultants or care coordinators.
• Ensure adherence to consent procedures, providing information to patients, carers, and next of kin regarding research methods and treatment decisions.
• Stay informed about developments in research practices to ensure compliance with current legislation and guidance.
• Conduct clinical assessments based on specific eligibility criteria.
• Organize and manage defined procedures, assist with intervention treatments, and collect and record relevant data.
• Undertake training in psychometric assessments and monitor trial procedures.

Research Responsibilities

• Exercise professional judgment in identifying suitable patients for clinical trials based on eligibility criteria.
• Register and randomize patients into the clinical database.
• Ensure accurate and complete data collection, maintaining databases and computerized systems, and creating spreadsheets for patient tracking.
• Ensure adherence to trial protocols by all members of the multidisciplinary team, coordinating follow-up appointments and required tests.
• Maintain source data, case report forms, and all other trial documents in a manner conducive to audit.
• Report adverse events following study procedures, including expedited reporting of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions.
• Coordinate investigations, collect samples, and ensure safe storage of specimens as part of the clinical research protocol.
• Play a key role in obtaining informed consent from service users and carers for participation in clinical trials.
• Manage data queries, follow-ups, and trial closure responsibilities.
• Participate in clinical audits and Research and Development activities, including nurse-led research projects.

Communication Responsibilities

• Support the Research Unit Coordinator and Head of the CRU-POAN in establishing effective communication systems for disseminating research findings.
• Collaborate closely with the research team and stakeholders, including Trust staff, multidisciplinary team members, service users, carers, families, and the broader research community.

Professional Development and Portfolio Management

• Complete mandatory Trust training and ensure timely supervision.
• Attend mandatory study training as required.
• Collaborate with the medical team/sponsor organization on study treatment and patient follow-up.
• Assist in the administrative management of the CRU-POAN portfolio.
• Take accountability for professional actions, working autonomously without direct supervision.
• Demonstrate specialized mental health site-specific knowledge relevant to the area of practice.
• Assume responsibility for continuous education by attending workshops, seminars, conferences, and courses, while staying updated on current publications.

Service Development

• Support service development by empowering service users, their relatives, and/or carers to actively participate in research activities.
• Contribute to the development and maintenance of Trust R&D standard operating procedures (SOPs).