Research Nurse - Sexual Health & HIV

• Coordinate and deliver a portfolio of clinical research studies from study set-up through to study closure and archiving.
• Arrange, conduct and manage participant research visits in accordance with study protocols.
• Obtain informed consent from research participants and ensure ethical and regulatory compliance.
• Collect, record and manage research data, including completion of electronic Case Report Forms (eCRFs).
• Deliver research studies in line with study protocols, regulatory requirements and ICH-GCP guidelines.
• Work independently to achieve recruitment, participant follow-up and data completion targets within agreed timelines.
• Collaborate with investigators, clinical teams, academic partners, sponsors and other stakeholders to support high-quality research delivery.
• Undertake participant trial procedures, including venepuncture, clinical sample collection and processing, and ECG recording.
• Coordinate specimen collection, handling, shipment and tracking in accordance with study requirements.
• Arrange, facilitate and support sponsor monitoring visits and study audits.Maintain accurate, complete and up-to-date study documentation, site files and regulatory records.
• Support the delivery of both commercial and non-commercial research studies, including CTIMPs and non-CTIMPs.
• Contribute to research studies across a range of specialities including HIV, sexually transmitted infections, contraception, genital dermatology, womens health and public health.
• Promote equality, diversity and inclusion in research by supporting representative participant recruitment and improving access for underrepresented groups.
• Work sensitively and compassionately with patients, recognising the stigma and barriers experienced by some participant groups.
• Identify, escalate and resolve issues affecting study delivery, participant recruitment and retention.
• Liaise with sponsors and monitors to address study findings and ensure timely resolution of actions.
• Contribute to achieving study performance metrics, including recruitment targets and time-to-target objectives.
• Support, guide and share knowledge with junior colleagues and less experienced research staff.
• Contribute to the ongoing development and improvement of the research service.
• Work across Axess Regional Clinic sites where necessary

• Knowledge of ICH-GCP guidelines and Research Governance requirements.
• Understanding of clinical trial processes and research delivery pathways.
• Knowledge of informed consent procedures and participant safety requirements.
• Understanding of data protection, confidentiality and record-keeping standards.
• Understanding of equality, diversity and inclusion principles in research.
• Understanding of the importance of representative recruitment and equitable access to research opportunities.

Essential

• Demonstrable experience of patient education and counselling, e.g. providing lifestyle advice
• Clinical experience/qualification in venepuncture, IV cannulation
• Supervision of student nurses
• Previous experience of co-ordinating clinical research studies
• Experience of liaison with staff at all levels in Healthcare

Essential

• Knowledge of the principles and practice of clinical research and/or clinical trials
• Understanding of the role & responsibilities of a Clinical Research Nurse
• Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive on ICH GCP requirements
• Knowledge of the Health Service, R&D, the pharmaceutical industry partnership and relevant information sciences

Essential

• Ability to use a personal computer, (computer literacy and proficiency in MS Office / EDCL)
• Skills in administration and project management
• Good communication, presentational, training and interpersonal skills
• Ability to meet tight deadlines and cope in a highly demanding environment
• Ability to work independently and prioritise / own workload and to communicate effectively with all members of the multi-disciplinary team
• Excellent and effective verbal and written communication skills

Desirable

• Skills in handling and management of computerised data
• Skills required to evaluate and assist in developing new protocols
• Skills in the analysis and interpretation of data

Essential

• Possession of tact and sensitivity to the needs of both patients and colleagues, including a commitment to confidentiality
• Meticulous attention to detail and a high standard of accuracy
• Flexible approach to working hours