This role is being advertised to cover a long term career break for 10months with a view to extend the post beyond this should funding become available. The aim of this role is to enhance the overall delivery of clinical research within the Trust by providing support to the existing research team, assisting with clinical and administrative activities related to clinical trials, from initiation to termination, in accordance with ICH Good Clinical Practice guidelines.

Main duties of the job

The post holder will be expected to manage participants in a portfolio of clinical research studies. They will have duty of care in supporting them and their families throughout their participation in any research activity. Acting as the participants advocate at all times. The Clinical Research Practitioner will play a key role in ensuring that any research undertaken safeguards the psychological and physical well-being of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006.The role will include set-up, maintenance, and close down of clinical studies, in accordance with local, national and international legislation within various clinical areas. The post holder will be responsible for identifying suitable patients for clinical trials, assessing their suitability, ensuring informed consent is obtained as per protocol and local guidelines. In addition will be responsible for coordinating the logistics for patient visits and undertaking patient assessments in accordance with study protocol.The post holder will be required to work autonomously within professional practice guidelines and within the Research Governance Framework. They may need to work flexibly across disciplines to ensure the successful working of the clinical research projects they are assigned to.For detailed information please see Job Description.

About us

Chelsea and Westminster Hospital NHS Foundation Trust is one of England's top-performing and safest trusts. We operate two main acute hospital sites--Chelsea and Westminster Hospital and West Middlesex University Hospital--along with award-winning clinics across North West London.

Our nearly 7,500 staff care for a diverse population of 1.5 million, providing full clinical services, including maternity, A& E, and children's services, plus specialist HIV and sexual health clinics. The Care Quality Commission rates us 'Good' in safety, effectiveness, care, and responsiveness, and 'Outstanding' in leadership and resource use.

We continually invest in our facilities, including a £30m expansion of critical care at Chelsea and Westminster and an £80m Ambulatory Diagnostic Centre at West Middlesex.

We welcome applications for flexible working arrangements, accommodating requests where possible to support our staff and patient needs.

The Trust is committed to equality and welcomes applications from all, regardless of background. Adjustments can be made for disabled candidates. Early application is advised as vacancies may close once sufficient applications are received. If you haven't heard from us within three weeks of the closing date, your application was likely unsuccessful. Employment is subject to a six-month probationary period.

Some roles may require weekend shifts at multiple sites.

Job description

Job responsibilities

• Be compliant with the rules and applications of Good Clinical Practice (GCP) and other elements of Research Governance.
• Follow study protocol and update practice when relevant.
• To ensure that research study specific activities are undertaken as required by the research protocol.
• Facilitate and maintain (written and verbal) communication between the PI, research and clinical teams in ensuring that the study protocol is correctly implemented and research governance standards are met and maintained.
• Work according to Good Clinical Practice (GCP) and Research Governance standards at all times.
• Screen and randomize participants suitable for entry into the study.
• Support recruitment and adhere to research targets.
• Identify barriers to recruitment and escalate appropriately.
• To facilitate the informed consent process as instructed by the Principal Investigator (PI) and within the parameters of the protocol.
• Provide ongoing support to patients and volunteers with regards to their trial participation and act as a primary contact point for the research study participants.
• Deliver and supervise a high quality patient experience.
• Accountable for timely source documentation and data entry into Study Investigator Site File, Case Report forms and Electronic Case Report Forms (CRFs/eCRFs). Ensuring a high degree of accuracy according to current legislation, guidance and best practice, including Good Clinical Practice (GCP).
• To recognise and report/escalate concerns should any conflict with regulatory frameworks and legal requirements arise, as well as any deviations from the study protocol.
• Perform all visit observations and clinical procedures, such as monitoring vital signs, body measurements, height and weight, ECGs, venepuncture and other clinical skills in accordance with the study protocol, in line with Scope of Practice and Competencies.
• Undertake laboratory work as per study protocols, including processing, packaging, storing and transportation of samples.
• Handling the reimbursement of patient expenses incurred as a result of study participation.
• Contributing to effective stock control/maintenance.
• Ensure key staff are compliant with study training and maintain training records.
• To ensure all Adverse Events/Serious Adverse Events are reported in line with the Trusts Reporting policy.
• Ensure that all clinical trial databases and logs are maintained including updating patient recruitment data on our Local Performance Management System (EDGE)
• Work within the scope of research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures.
• Adhere to the confidentiality of patient information at all times, in accordance with the Data Protection Act and Caldicott regulations.
• To report to Senior Staff regarding progress of clinical studies.
• To work autonomously as well as the ability to collaborate within the MDT.
• Provide assistance with research projects/tasks as instructed by Senior Staff.

Person Specification

Education

Essential

• Research experience within an NHS or care setting
• ICH GCP-certificated
• Evidence of continuing professional development
• First degree (BSc/BA) or equivalent level of experience

Desirable

• Clinical Research Practitioner registration or a willingness to complete competencies to obtain registration within one year

Experience

Essential

• Clinical Research Experience at Band 4 level
• Experience of clinical trials
• Experience of working within a healthcare setting/NHS
• Experience of acting as a patient advocate
• Experience of teaching and supporting new starters
• Experience of working to deadlines and prioritising a busy workload

Desirable

• Practical clinical experience (including ECG, Venepuncture, Vital signs)

Skills and Knowledge

Essential

• Excellent level of English language demonstrated through effective written and verbal communication skills
• Able to manage challenging situations
• Ability to work autonomously and as a member of a team integrating with multidisciplinary teams
• Demonstrable IT skills including email and Microsoft office programs (including Excel, Word, PowerPoint, Teams and Outlook)
• Knowledge of patient information systems
• Experience of data collection/data management

Personal qualities

Essential

• Approachable, respectful, supportive, adaptable and assertive
• Effective team member
• Effective role model, demonstrating trust values
• Enthusiastic and motivated
• Ability to remain calm and professional under pressure
• Able to work on own initiative
• Commitment to achieving objectives of project
• Respect and promote Equality, Diversity and Inclusion

Employer details

Employer name

Chelsea and Westminster Hospital NHS Foundation Trust

Address

Chelsea and Westminster Hospital

369 Fulham Road

London

SW10 9NH

Any attachments will be accessible after you click to apply.

289-CR-1660