Clinical Research Practitioner
Job overview
Please note that these posts are fixed term 24 months contracts at 37.5 hours per week.
We are looking to appoint a Research Practitioner (Band 4) in the Melanoma Research team within The Christie NHS Foundation Trust. The research teams form part of the Research and Innovation division and are made up of a multi-disciplinary group of staff who are dedicated to cancer research and treatment.
We are seeking an enthusiastic, motivated, and experienced individual who will be responsible for assisting the research nurses, consultants and trial management team with the delivery of clinical research projects and clinical trials. We are looking for an individual who is able to demonstrate work experience in data management involving clinical trials, good understanding of clinical research, GCP and clinical trial governance.Strong candidates will have excellent organisation and communication skills, work well both in a team and using their own initiative.
Applicants should meet all the essential criteria on the job description as a minimum. We are looking for a candidate with good organisational and communication skills, with the ability to multi-task. Due to the vital nature of our work and the impact on patients and the research community, attention to detail is an essential skill.
An informal conversation to discuss the post is highly recommended.
Main duties of the job
The role will work across the clinical and administrative areas of the Melanoma research team. This will require working in clinical areas under the supervision of clinical research nurses and working in administrative areas under the supervision of the trial coordinators and research managers.The post-holder will provide clinical support for patients, within the boundaries of their own competence, and under the supervision and delegation of investigators and nurses. This will include tasks such as collecting biological samples, observations, data and quality of life questionnaires from trial participants.
The administrative role will involve the management of a portfolio of clinical projects with support from other colleagues. This includes entering data from patient visits, responding to trial queries, completing trial-related records, filing key trial documents, assisting with invoicing, working with members of the core Research and Innovation team, liaising with pharmaceutical contacts, and assisting colleagues with other administrative tasks.
Post holders will be expected to participate fully in their personal development and review process in order to achieve the objectives for this post. They should be in possession of, or working towards, the National Care Certificate
The role comes with full training, and the opportunity for additional training to support career development within the Trust.
Working for our organisation
The Christie NHS Foundation Trust is one of the largest cancer treatment centres in Europe, and an international leader in cancer research and development. We are one of the leading centres in the UK for clinical trials and radiotherapy research.Treating more than 40,000 patients a year, we are the first UK centre to be officially accredited as a comprehensive cancer centre. The Clinical Research Facility (CRF) at The Christie is also one of four specialist units in Manchester for experimental research that make up the NIHR Manchester CRF, providing us with the dedicated space and expertise required to deliver intensive and complex studies in safe environment.
Detailed job description and main responsibilities
DUTIES AND RESPONSIBILITIES
The specific responsibilities will depend on the requirements of each team, but may include:
Clinical- Provide clinical care for research participants, as delegated by PIs and research nurses, within the boundaries of own knowledge, competence and skill level.
- Ensure that all research is undertaken according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
- Planning and organising day- to-day research and other activities
- Conduct delegated data collection with participants, such as questionnaires and interviews.
- Collection of biological samples as required for the clinical protocol, this may include blood, urine, sputum etc.
- Preparation of sampling kits as described in study laboratory manuals, maintaining laboratory stock and shipping & tracking of research samples.
- Undertake research-related activities as required such as clinical observations and NEWS2, blood glucose monitoring, blood sampling (venepuncture and other venous access), PK sampling, cannulation and ECGs.
- Attend individual project meetings as required.
- Contribute to clinical and research governance processes, including adverse event and incident reporting, supporting any investigations.
- Understand and deliver care in accordance with regulatory approved clinical research protocols.
- Ensure all clinical activities are recorded in appropriate systems in a timely manner.
- Evening and weekend shifts may occasionally be required to meet the clinical needs of the service
- Act as a point of contact for the core Research and Innovation team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct.
- Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.
- Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
- Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
- Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner.
- Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.
- Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.
- Ensure that data is available and up to date for any meetings related to a clinical trial.
- If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
- Undertake general administrative tasks related to clinical trials as delegated by your line manager.
- Assist with preparation for audit and inspections within assigned teams.
- Work closely with the Research Division’s management team to ensure adherence to new SOPs and working procedures rolled out divisionally.
- Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
- The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Senior Clinical Trials Coordinators/ Research Nurses as necessary.
- Undertake continuous professional development, seeking opportunities to enhance skills via a personal development plan.
- Participation in trust-wide education programmes and study days.
- To keep up to date with departmental, Trust, UK and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
Person specification
Qualifications
Essential criteria- Minimum GCSE or equivalent Math and English. NVQ level 3 or relevant experience.
- A research qualification / clinical research training
- Degree in science or health-related discipline
- National Care certificate (Christie Care Certificate)
Experience
Essential criteria- Experience of working in a research environment Or At least 12 months working in a healthcare environment
- Data management experience
- Clinical research experience
- Phlebotomy skills
Skills
Essential criteria- IT skills. Experience of using Email, Excel, Word and Outlook
- Evidence of IT training
- Intra-venous access training, or a willingness to undertake this
Knowledge
Essential criteria- Awareness of ICH “Good Clinical Practice”.
- Knowledge and understanding of patient observations
- Knowledge of the clinical trial process.
- Understanding of medical terminology and cancer.
- Knowledge of patient information systems
Values
Essential criteria- Ability to demonstrate the organisational values and behaviours
Other
Essential criteria- Ability to work on own initiative
- Ability to organise and prioritise own workload
- Ability to work as part of a multi-disciplinary team.
- Able to work flexibly and to tight deadlines.
- Ability to communicate effectively at all levels
The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.
We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels.In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.
We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.
As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy
All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.
By applying for this post you are agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system.Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.
If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.
The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.
Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.
You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.