Clinical Research Coordinator ( HCA Qualified)

Job Title: Clinical Research Coordinator ( HCA Qualified)

Salary: £32,000 per annum

Responsible To: Senior Research Facilitator

Hours: Full time

Clinical Accountability: Research Nurse / appropriately qualified clinical lead

Contract: 6Months initially

Location: CLH research clinics

Base: On-site, with flexibility across services

Key Relationships: Director of Research and Business Intelligence; Research Manager; Senior Research Facilitator; Research Nurses and clinicians; GP practices and PCNs; patients and research participants; NIHR/RRDN; sponsors and Contract Research Organisations; CLH Communications and Corporate teams; community and tertiary care partners.

Central London Healthcare CIC (CLH) is a federation supporting 31 General Practices and 3 Primary Care Networks in Westminster. CLH provides community and primary care services, as well as staffing, management and administrative support to member practices. CLH also works collaboratively with local, NHS, academic, community and commercial partners, including through research and consultancy.

Our approach is to deliver exceptional assistance to our General Practice members and to operate services in a way that supports practices and patients economically, locally, promptly and in a familiar environment.

Our purpose is to transform health and wellbeing in our communities. Our vision is to be the healthcare provider of choice, rooted in primary care.

Compassionate: We listen respectfully, offer the opportunity for different viewpoints and are kind to each other.

Accountable: We work with integrity, taking accountability for our work to achieve the highest quality outcomes.

Resilient: We listen to feedback and continually build and improve.

Pioneering: We champion change, embrace creativity and promote innovation and new ways of thinking.

Aspirational: We nurture and motivate so our people are enabled to reach their full potential.

The Research Healthcare Assistant will work as part of the CLH Research Team, providing both clinical and non-clinical support to the safe, effective and efficient delivery of commercial and non-commercial research studies and research clinics. The post holder will combine core Healthcare Assistant duties with participant-facing research support, clinic coordination, study administration, recruitment activity and accurate information management.

All clinical procedures must be undertaken only where the post holder has received appropriate training, has been assessed as competent and is working under an approved study protocol, local policy, delegated authority and appropriate clinical oversight. The post holder must not work beyond their competence or the scope of the role.

The role is primarily on-site and will require flexible working across CLH research clinics, GP practices, hub sites and other community or partner locations according to service and study requirements.

Clinical and participant-facing duties

• Undertake and record clinical observations and procedures for which training and competency have been completed, as required by the relevant study protocol or clinical service. These may include blood pressure and pulse, height, weight and body mass index, urinalysis, blood glucose measurement, ECGs, peak flow, spirometry, smoking status and health checks.

• Undertake venepuncture and process pathology or research samples in accordance with study instructions, infection prevention requirements and local procedures.

• Support research nurses and other appropriately qualified clinicians with participant assessments, clinical examinations and procedures, including preparation of rooms, equipment and documentation.

• Administer medicines or vaccinations only where the post holder is trained, competent and authorised under the appropriate legal mechanism and local policy.

• Act as a chaperone where required and support privacy, dignity, comfort, communication and reasonable adjustments for participants and patients.

• Recognise and respond appropriately to deterioration, urgent situations, adverse events or participant concerns, escalating promptly to the research nurse or appropriate clinician and following emergency procedures.

• Give clear, accurate and appropriate information within the boundaries of the role, referring clinical or study-specific questions to an authorised member of the research team.

• Maintain clean, safe and well-prepared clinical environments and equipment before, during and after interventions, in line with infection prevention and control requirements.

• Support health promotion and improve awareness of appropriate research opportunities and services without exerting pressure on potential participants.

Research operations and clinic coordination

• Support the Research Manager, Senior Research Facilitator, research nurses and wider research team with the smooth running of research clinics.

• Assist with participant identification and recruitment activities in accordance with approved study processes, including sending invitations, appointment reminders and supporting follow-up communications.

• Facilitate participant bookings and coordinate clinical examination appointments with CLH services, GP practices, community clinics and tertiary partners as directed.

·       Maintain meticulous, accurate, and comprehensive source documentation and Case Report Forms (CRFs/eCRFs). Resolve data queries efficiently with study monitors and sponsors.

·       Maintain the Investigator Site File (ISF) or Trial Master File (TMF), ensuring all documentation (e.g., CVs, training logs, delegation logs) is current

• Monitor and update research clinic rotas and patient bookings on SystmOne and other approved platforms.

• Support participant reimbursement processes and maintain accurate related records, escalating queries appropriately.

• Maintain clinical and research equipment, consumables and stock levels; complete required checks, stock rotation and replenishment, and report faults or shortages.

• Assist with the set-up, delivery and close-down of commercial and non-commercial studies, including collating paperwork and following up outstanding operational actions.

• Support recruitment monitoring and contribute accurate information for team, study and research committee reporting.

Research administration and documentation

• Create and maintain document templates, filing systems, trackers, alerts, distribution lists and clinic records as required.

• Organise study documents on approved MS Teams channels and other authorised systems, maintaining version control and confidentiality.

• Support the research team with Standard Operating Procedure updates and ensure current approved instructions are readily available.

• Prepare participant invitation letters, text messages, clinic materials, meeting information and routine correspondence using approved templates.

• Assist with financial administration, purchase requests, invoice preparation and payment queries as directed.

• Support the preparation of slide decks and updates for bi-weekly research team meetings and monthly research committee meetings.

• Liaise with CLH Communications and Corporate teams to provide approved research updates and help maintain accurate research webpage, intranet and newsletter content.

Information management, systems and data quality

• Enter and maintain accurate, timely and complete clinical and research records in SystmOne, study databases, trackers and other approved systems.

• Extract information from SystmOne or approved Excel files for authorised feasibility checks, recruitment uploads and reporting, under appropriate direction.

• Run approved SystmOne searches for feasibility work when required and appropriately authorised, particularly in the absence of the Senior Research Facilitator.

• Support monitoring of recruitment activity and data quality for current studies, identifying discrepancies and escalating them promptly.

• Ensure research clinicians have the relevant authorised system access for eligibility checks and clinic delivery, escalating access issues to the appropriate lead.

• Handle personal and confidential information in accordance with data protection, information governance, study requirements and CLH policy.

Governance, safety and professional responsibilities

• Work in accordance with Good Clinical Practice principles, approved protocols, delegation logs, Standard Operating Procedures, CLH policies and applicable professional and legal requirements.

• Obtain or confirm informed consent only where this is explicitly delegated, the post holder is trained and competent, and the study protocol permits it; otherwise support the consent process administratively and refer to an authorised member of the study team.

• Recognise safeguarding concerns and raise them promptly through the appropriate CLH or host-site pathway.

• Report incidents, protocol deviations, adverse events, near misses, complaints, equipment issues and data-quality concerns promptly to the appropriate lead.

• Participate in mandatory training, study-specific training, competency assessment, supervision, appraisal, team meetings, audits and service improvement activity.

• Work collaboratively with colleagues and external partners, communicating professionally and maintaining clear boundaries.

• Assist with the induction or practical support of colleagues where appropriate and within competence.

• Undertake other duties reasonably consistent with the scope and grading of the post. The list of duties is not exhaustive

PERSON SPECIFICATION

Criteria

Qualifications and training

Essential

Care Certificate or equivalent relevant experience. Phlebotomy training and competency. Relevant clinical skills training and competency for duties undertaken.

Desirable

Good Clinical Practice training. ECG, spirometry, wound care and IM injection training where required by the role. Relevant health, care or research qualification.

Criteria

Experience

Essential

Experience in a patient-facing healthcare setting. Experience undertaking observations/procedures within competence. Experience maintaining accurate records and handling confidential information.

Desirable

Experience in primary care and/or a research setting. Experience supporting research clinics, participant recruitment or study administration. Experience using SystmOne.

Criteria

Knowledge

Essential

Understanding of confidentiality, data protection, safeguarding, infection prevention and the limits of own competence. Awareness of patient dignity, equality and inclusive communication.

Desirable

Knowledge of medical and research terminology, NHS policies and procedures, and the principles of Good Clinical Practice.

Skills

Essential

Strong interpersonal and communication skills. Accurate clinical and administrative record keeping. Good organisation, prioritisation and attention to detail. Ability to use Microsoft Office, web-based applications, databases and reporting tools. Ability to work independently and as part of a multidisciplinary team.

Desirable

Ability to use SystmOne confidently, support data extraction and searches, maintain trackers, and contribute to presentations or routine reports.

Personal attributes

Essential

Compassionate, accountable, reliable and professional. Flexible and solution-focused. Able to work calmly under pressure and communicate tactfully with people from a wide range of backgrounds. Willing to learn and undertake ongoing competency assessment.

Desirable

Demonstrates enthusiasm for research, service improvement and improving access to research opportunities.

• The post holder must maintain confidentiality and comply with CLH policies, host-site requirements and all mandatory training obligations.

• The role may involve travel between CLH, practice, clinic and partner sites and may require flexible working according to research clinic schedules.

• Clinical duties and research activities may vary by study. Any additional duty must be appropriate to the post holder’s training, competence, delegated responsibilities and the approved study or service requirements.

• This job description may be reviewed as the service develops, following discussion with the post holder.