Clinical Research Practitioner (CRP) Chelsea and Westminster Hospital NHS Foundation Trust

Fernie Brewing Company; London; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player in clinical research is seeking a dedicated Clinical Research Practitioner to enhance the delivery of clinical trials. This role involves managing participants, ensuring compliance with Good Clinical Practice (GCP), and supporting the research team throughout the clinical study lifecycle. You will play a vital role in safeguarding patient well-being while coordinating logistics and assessments in accordance with research protocols. If you are passionate about clinical research and patient advocacy, this is an excellent opportunity to make a significant impact in a supportive and innovative environment.

Benefits

Flexible working arrangements

Support for disabled candidates

Career development opportunities

Comprehensive training programs

Qualifications

• Experience in clinical research and compliance with GCP guidelines.
• Ability to manage participants and facilitate informed consent.

Responsibilities

• Manage participants in clinical research studies and ensure their well-being.
• Coordinate logistics for patient visits and conduct assessments.

Skills

Good Clinical Practice (GCP)

Clinical Research

Patient Management

Informed Consent Process

Data Entry

Clinical Procedures

Education

Degree in Life Sciences or related field

Clinical Research Certification

Tools

Electronic Case Report Forms (eCRFs)

Local Performance Management System (EDGE)

Job description

This role is being advertised to cover a long-term career break for 10 months 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.

The post holder will be expected to manage participants in a portfolio of clinical research studies. They will have a 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, they 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.

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.

1. Be compliant with the rules and applications of Good Clinical Practice (GCP) and other elements of Research Governance.
2. Follow study protocol and update practice when relevant.
3. Ensure that research study specific activities are undertaken as required by the research protocol.
4. 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.
5. Work according to Good Clinical Practice (GCP) and Research Governance standards at all times.
6. Screen and randomize participants suitable for entry into the study.
7. Support recruitment and adhere to research targets.
8. Identify barriers to recruitment and escalate appropriately.
9. Facilitate the informed consent process as instructed by the Principal Investigator (PI) and within the parameters of the protocol.
10. 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.
11. Deliver and supervise a high-quality patient experience.
12. Accountable for timely source documentation and data entry into Study Investigator Site File, Case Report forms and Electronic Case Report Forms (CRF’s/eCRFs), ensuring a high degree of accuracy according to current legislation, guidance, and best practice, including Good Clinical Practice (GCP).
13. Recognize and report/escalate concerns should any conflict with regulatory frameworks and legal requirements arise, as well as any deviations from the study protocol.
14. 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.
15. Undertake laboratory work as per study protocols, including processing, packaging, storing, and transportation of samples.
16. Handle the reimbursement of patient expenses incurred as a result of study participation.
17. Contribute to effective stock control/maintenance.
18. Ensure key staff are compliant with study training and maintain training records.
19. Ensure all Adverse Events/Serious Adverse Events are reported in line with the Trust’s Reporting policy.
20. Ensure that all clinical trial databases and logs are maintained including updating patient recruitment data on our Local Performance Management System (EDGE).
21. Work within the scope of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.
22. Adhere to the confidentiality of patient information at all times, in accordance with the Data Protection Act and Caldicott regulations.
23. Report to Senior Staff regarding progress of clinical studies.
24. Work autonomously as well as the ability to collaborate within the MDT.
25. Provide assistance with research projects/tasks as instructed by Senior Staff.

This advert closes on Wednesday 18 Dec 2024.