Job Summary
We're looking for a full-time Band 5 Clinical Research Practitioner to coordinate and deliver clinical research studies at The Christie NHS Foundation Trust.
We are looking for a highly motivated and enthusiastic individual who can contribute to the development of clinical research for people with cancer within the Oesophago-Gastric (OG) and Renal Research Team.
The role of the CRP will involve recruiting patients to these clinical trials, obtaining informed consent where appropriate, supporting patients enrolled in clinical trials, and ensuring study interventions are completed according to Good Clinical Practice (GCP) and Trust standards.
You will be working within a supportive team of experienced clinical research nurses and the clinical trial administration team.
Main duties of the job
The post will involve coordinating a portfolio of research studies across different specialties (OG and Renal) within the Trust. We are seeking candidates with experience in working in clinical research in the NHS that can demonstrate knowledge of Good Clinical Practice and clinical skills, such as phlebotomy. Strong communication and organisational skills are essential, and a flexible working approach is a key element to this role.
Job responsibilities
Clinical Research Delivery & Co-ordination
1. To act as a primary contact point for the clinical trial patients for defined clinical trials and act as adviser to other health care professionals.
2. Interview, recruit, take informed consent and support patients and carers in clinical trials/studies.
3. Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required.
4. Be responsible for the safe and accurate collection of research samples and data, through clinical procedures such as venepuncture, and history taking.
5. Centrifuge, process, track and ship samples in line with protocol requirements.
6. Work with the clinical trials team and investigators to develop strategies to overcome barriers to recruitment.
7. Work with other departments within the Trust to ensure that trial specific investigations and procedures are undertaken as required by the trial protocol.
8. Act as a key point of contact with the R&D core team, study sponsors, clinical research organisations and specific research teams.
9. Manage the set up and initiation of allocated clinical trials within assigned Clinical Research Teams.
10. Understand and deliver protocols in accordance with regulatory requirements.
11. Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.
12. Maintain adequate patient records and ensure all relevant information is documented in the patients' notes.
13. Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.
14. Ensure that all documents are archived in the appropriate way by following the Trust's archiving guidelines.
15. Attend research team meetings to maintain an overview of team activity.
Clinical Service Responsibilities
1. Demonstrate awareness of divisional and trust strategic objectives including performance indicators and metrics.
2. Escalation of governance issues impacting on delivery of job purpose.
3. Participate in monitoring and audit activities within research team.
Management
1. Provide induction support and training to new and existing clinical trials staff.
2. Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.
3. Assist with metric tracking for performance indicators.
PERSONAL AND PEOPLE DEVELOPMENT
1. Maintain professional development whilst evaluating own specialist knowledge.
2. Participate in and deliver Trust-wide education programmes and study days.
PHYSICAL, MENTAL AND EMOTIONAL EFFORT
1. Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
2. Prolonged concentration is regularly required.
3. Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.
Person Specification
Qualifications Essential
* Scientific Degree or relevant experience in scientific and medical research.
Experience Essential
* Experience in clinical trials administration, data management involving clinical trials or project coordination.
* Experience of working within a health care system and within a multidisciplinary clinical team.
* NHS experience.
Skills Essential
* Excellent organisational skills.
* Excellent interpersonal skills.
* Good oral and written communication skills.
* IT literate.
* Attention to detail.
Knowledge Essential
* Understanding of clinical research GCP guidelines/EU directives.
* Knowledge of clinical governance.
* Knowledge of patient information systems.
Values Essential
* Ability to demonstrate the organisational values and behaviours.
Other Essential
* Tactful and diplomatic.
* Flexible.
* Conscientious and hardworking.
* Ability to work unsupervised or as part of a team.
* Ability to work to tight and/or unexpected deadlines.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service. #J-18808-Ljbffr