Overview
Job Summary
The Clinical Research Nurse is responsible for coordinating and conducting clinical research studies while delivering high-quality participant care in accordance with study protocols, UK Good Clinical Practice (GCP), ICH-GCP guidelines, Medicines and Healthcare products Regulatory Agency (MHRA) requirements, and Company Standard Operating Procedures (SOPs). The role combines advanced clinical nursing practice with clinical trial management responsibilities to support participant safety, protocol compliance, and data integrity throughout the lifecycle of a clinical study. This includes leadership in participant care, study conduct, investigational product administration,
Responsibilities
Duties and Responsibilities
- Coordinate and conduct clinical research studies in accordance with approved protocols, UK GCP, ICH-GCP guidelines, MHRA requirements, and Company SOPs.
- Provide direct nursing care to research participants throughout all phases of study participation.
- Perform protocol-required clinical procedures, including venepuncture, cannulation, vital signs assessment, electrocardiograms (ECGs), clinical assessments, drug preparation and administration, and specimen collection and processing.
- Administer investigational medicinal products (IMPs) in accordance with protocol requirements and nursing scope of practice.
- Monitor participants for adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), ensuring timely reporting and escalation.
- Conduct informed consent discussions and support ongoing participant understanding and consent throughout study participation.
- Coordinate participant scheduling and study visits.
- Support participant recruitment, screening, enrolment, retention, and follow-up activities.
- Maintain accurate source documentation and ensure timely and complete data entry into sponsor and vendor electronic systems.
- Resolve data queries and collaborate with sponsors, Contract Research Organisations (CROs), and study teams to support data quality.
- Support protocol implementation, study start-up activities, amendments, and close-out processes.
- Maintain accountability for participant safety and protocol compliance.
- Assist with regulatory document preparation, maintenance, and submission as required.
- Collaborate effectively with investigators, sponsors, CROs, pharmacies, laboratories, and other healthcare professionals.
- Mentor and support junior clinical staff and research personnel as appropriate.
- Contribute to quality improvement initiatives and study process enhancements.
- Promote respect for cultural diversity and maintain a participant-centred approach to care.
- Perform other duties as assigned.
Qualifications
Required Skills and Abilities
- Advanced clinical assessment skills.
- Strong knowledge of Good Clinical Practice principles.
- Demonstrated understanding of clinical research methodology and clinical trial conduct.
- Advanced verbal and written communication skills.
- Strong organisational and project-management skills.
- Ability to work independently and manage multiple competing priorities.
- Strong attention to detail and commitment to quality.
- Ability to build effective working relationships with participants, investigators, sponsors, and multidisciplinary teams.
- Proficiency in Microsoft Office applications and electronic data capture systems.
- Strong problem-solving and critical-thinking skills.
- Commitment to participant safety, confidentiality, and ethical research practices.
Education and Experience
Essential
- Registered Nurse qualification.
- Current registration with the Nursing and Midwifery Council (NMC).
- Minimum of 2 years of post-registration nursing experience.
- Experience working within a healthcare environment involving direct patient care.
Desirable
- Previous clinical research experience.
- Experience administering investigational or specialist therapies.
- Experience in outpatient, acute care, research, or specialist clinical settings.
- Qualification or training in clinical research or research governance.
Required Licences and Certifications
Essential
- Active Nursing and Midwifery Council registration without restrictions.
- Valid GCP certification or willingness to obtain within three months of hire.
Desirable
- Advanced clinical skills certifications relevant to the specialty area.
- Certification from ACRP, SoCRA, or an equivalent clinical research professional organisation.
Physical Requirements
- Ability to sit, stand, and walk for extended periods.
- Ability to perform clinical nursing procedures safely and effectively.
- Ability to communicate effectively in person, virtually, and by telephone.
- Ability to safely move clinical supplies and equipment as required.
- Occasional travel for training, investigator meetings, or study-related activities.
ROLE SCOPE
The duties and responsibilities described above are intended to communicate the general nature and level of work performed in this position. They are not an exhaustive list of all duties, responsibilities, or qualifications required. Duties may change based on operational, regulatory, and business requirements. All employees are expected to perform duties within their capabilities and professional scope of practice as requested by management.
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