Clinical Research Nurse - Gynaecology

Job overview

We are looking for a highly motivated and enthusiastic Clinical Research Nurse for Gynaecology to join the Women's Health Research Team.

The role is funded until 31/03/2026 and funding may not renew.

The post holder will be responsible for recruiting to, and following up, patients in trials and studies adopted by the National Institute of Health Research (NIHR) and commercial companies. Key responsibilities will include supporting and coordinating a broad research portfolio, ensuring trials are set up and managed in accordance with regulatory, sponsor and local Research & Innovation (R&I) requirements.

Expected to attend ward rounds, clinics and multi-disciplinary meetings to identify participants suitable for entry into trials. The post holder is expected to work as part of a team and autonomously, ensuring research governance and patient safety are prioritised at all time.

Previous research experience is preferred but not essential but must have genuine interest in clinical research.

Main duties of the job

• Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings
• Collaborate with the Research Manager and the team to oversee multiple trials, ensuring strict adherence to trial protocols and governance within EU clinical trial directives and ICH GCP guidelines, while upholding a duty of care to patients and their families.
• Consenting patients to trials
• Support and help coordinate the research patient pathway from screening through to trial closure
• Maintain adequate patients’ records and ensure all relevant information is documented in the patient’s medical and nursing notes
• Be responsible for accurate completion of Case Report Forms (CRFs) delegated to them.
• Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials
• Undertake agreed trial procedures, in line with trial and Trust procedures, to include venepuncture, temperature, pulse, blood pressure checks, ECGs, height, weight, urinalysis and measuring O2 sats and respiratory rate. 

Working for our organisation

King’s College Hospital NHS Foundation Trust is one of the UK’s largest and busiest teaching Trusts with a turnover of £1 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King’s College Hospital (KCH) in Denmark Hill, the Princess Royal University Hospital (PRUH) in Bromley, Orpington Hospital and services at Queen Mary’s Hospital, Sidcup and the Beckenham Beacon.

The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King’s to another level.

We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.

Detailed job description and main responsibilities

Main Duties and Responsibilities

1.0 Clinical and Research

1. 1.1  Work autonomously to carry out planned care required by the research protocols within the portfolio of clinical research within the department, whilst working as part of a multidisciplinary team.

2. 1.2  Promote equal opportunities for involvement in research across all clinical sites

3. 1.3  Facilitate efficient, safe and woman focused research including screening procedures, biological sample collection and all clinical observations required to ensure and maintain

   participant safety before, during and after the research visit

4. 1.4  Ensure that Good Clinical Practice, research, and clinical governance standards for

   clinical research are adhered to and maintained

5. 1.5  Ensure all data is stored and transferred in line with GCP, GDPR, Trust guidelines and

   sponsor agreements and to ensure robust procedures for participant confidentiality are

   developed and adhered to

6. 1.6  Ensure that written informed consent has always been obtained for any treatment

   provided for, or any sample or data taken from a Volunteer which will form part of a

   research study, in accordance with the Trust research governance arrangements.

7. 1.7  Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that the trial is conducted according to the Medicines for Human Use (Clinical Trial)

   Regulations 2004 and Amended Regulations 2006 where appropriate.

8. 1.8  Ensure the safe administration of the investigational medicinal product (IMP), have in- depth knowledge of the legal requirements of the individual Trust’s clinical trial pharmacovigilance and pharmacovigilance policies. Report any adverse events and reactions in accordance with this policy and the trial protocol. Report any serious adverse events within 24 hours of knowledge of the event, to the sponsors. (For non- commercial studies please use the appropriate SAE forms supplied by the host sites. For KCH & GSTT-sponsored non-commercial studies, please use KHPCTO forms).

1. 1.9  Work with Women’s Health Research Manager and the Chief and Principal investigators to develop local recruitment strategies, identifying required workforce and skill mix to deliver local studies

2. 1.10  Identify barriers to recruitment and implement necessary action plans.

3. 1.11  Ensure inclusive research to address inequality in care/outcomes and participation in

   research

4. 1.12  Perform tasks requiring highly developed clinical skills including phlebotomy,

   cannulation, etc and the administration of trial drugs, and to keep up to date with current

   practices for cannulation, phlebotomy etc,

5. 1.13  Oversee the routine maintenance, monitoring and servicing of clinical equipment

6. 1.14  Ensure all data is stored and transferred in line with GCP, GDPR, Trust guidelines and

   sponsor agreements and to ensure robust procedures for participant confidentiality are developed and adhered to. To be responsible for the delivery team’s compliance with data entry protocols ensuring data is compiled and transferred in a timely manner

7. 1.15  Report any deviation from normal practice to senior staff and implement agreed changes in care programme

8. 1.16  Deal with concerns raised by volunteers and visitors in a proactive manner and take remedial action as necessary

9. 1.17  Act as the patient advocate

10. 1.18  Support the clinical services in times of extreme workload or escalation.

2.0 Administration

1. 2.1  Delegate to research staff according to ability and workload to meet study needs

2. 2.2  Assist with study set up, including feasibility assessment and supporting timely local

   permissions for research studies

3. 2.3  Assist the PIs in liaising with the KHPCTO and R&I Office relating to submission of the

   study for regulatory approval and Trust Management approval. Assist in completing

   submissions to the Research Ethics Committee as required.

4. 2.4  Work with the Senior Clinical Research Midwives to ensure studies meet time and target,

   employing strategies to resolve any barriers that arise

5. 2.5  Assist in the role out Standard Operating Procedures within your department where

   indicated

6. 2.6  Represent King’s College NHS Foundation Trust as a research nurse in external

   situations, for example national and international conferences, committees etc.

7. 2.7  Support the Senior Clinical Research Midwives in the management of complaints, accidents and incidents in accordance with Trust protocol, raising any adverse

   incident/near misses in a timely manner

8. 2.8  Ensure that investigators’ GCP certificates and CVs are always valid.

9. 2.9  Ensure the economical use of resources

3.0 Training and Education

1. 3.1  Assist with ensuring mandatory clinical research training is undertaken and updated as required

2. 3.2  Provide training to research and clinical staff on research generally and study specific protocols where necessary

3. 3.3  Maintain and develop your own research knowledge and skills utilizing opportunities for involvement in research development

1. 3.4  Provide information to service users, individually or through forums, on research that is ongoing or potential

2. 3.5  Assist with the dissemination of research findings.

Person specification

Education and Qualifications

Essential criteria

• Registered Nurse
• Evidence of ongoing and sustained CPD
• Good Clinical Practice

Desirable criteria

• Masters’ qualification or demonstrated ability to work at this level
• Mentorship qualification
• A track record of research

Knowledge and Experience

Essential criteria

• Evidence of clinical experience and ability to function at level X required of the post
• Current experience of clinical nursing practice
• Understanding of the local priorities within the local health X community
• Knowledge of scientific conduct of clinical research including the X planning, co-ordination and conduct of clinical trials
• Knowledge of quality standard setting and audit
• Awareness of Equality and diversity issues

Desirable criteria

• Clinical research practice in Reproductive Health and Childbirth
• Leading the set-up and delivery of clinical trials
• Experience of data capture and database management
• Evidence of research and or audit
• Experience of teaching

Skills and Competencies

Essential criteria

• Excellent verbal and written communication skills including X presentations and publications
• Highly developed interpersonal skills with meticulous attention to X detail
• Able to represent and advocate for women’s health research
• Computer literature, including use of excel, word, powerpoint, X internet and email
• Research delivery skills from assessment of feasibility to study X close
• Knowledge of Good Clinical Practice and research governance, X including data protection
• Flexible to meet service needs
• Ability to Work under pressure and to meet deadlines. X Demonstrates awareness of priorities, deals with workload, adapts to changing requirements, and uses initiative
• Ability to compile, analyse and disseminate complex information
• Able to act as an effective role model
• Maintain confidentiality and is accountable for actions/ decisions
• Problem solver
• Calm under pressure
• Reliable
• Able to identify opportunities to develop needs and to change X existing practice

Desirable criteria

• Basic laboratory skills e.g. centrifuge, sample separation

IMPORTANT

• Check your email account regularly as this is how we will communicate with you
• If you delete the job from any of your accounts, you may be prevented from accessing further communications
• To enquire about your application or inform us of any changes in your circumstances, please contact the named person on this advert
• Please provide email addresses for referees where possible
• Please review the documentation on our recruitment microsite, particularly the Trust’s criminal records checking policy
• All staff have a responsibility for safeguarding children and vulnerable adults and for ensuring they are aware of the specific duties relating to their role.
• Please note that the closing date is given as a guide. On occasion, we might close a vacancy early due to a high number of applications being received. You are advised to submit your application as early as possible to avoid disappointment.

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