Clinical Trials Assistant

Job summary

Clinical TrialsAssistant (CTA) Primary Care Research

Salary Band: BandC

Hours: Monday to Friday, hours per week (Longer Days working hours over 4 days may bepossible)

This is an exciting opportunity for a Clinical Trials Assistant to join thePrimary Care Sheffield Research Office.

We arelooking for a reliable, enthusiastic, and motivated Clinical Trials Assistantto work with this forward-thinking service, which provides excellent care andhas a passion for improving health outcomes for patients.

Weare happy to meet informally to provide further information and would love tohear from you. For further information in the first instance please contactMel Celikkol (Research Service Manager)

Main duties of the job

The primary focus of this role is to support the Research Team,working closely with all members of the multidisciplinary team, to increasepatient recruitment into clinical trials, and to contribute to a high-qualityresearch service and adherence to trial protocols. To work under the guidance and supervision of the Research Team members to meetthe needs of the study participants who have voluntarily consented to take partin a clinical research study.

The post holder will be expected to interact with study teams,patients, and their families about the requirements of the clinical trials andbe able to work without supervision in some areas. The post holder will also be required to provide dedicated clinical trialssupport in the form of collecting data and data entry in all studies (treatment/observations),assisting in the set-up of clinical trials and ongoing documentation associatedwith clinical trials, assisting with the identification of appropriate patients,receiving consent, recruiting, supporting and monitoring patients inobservational studies.

There will be a requirement to manage observationsfollowing appropriate training and mentorship.

About us

Primary Care Sheffield(PCS) are a social purpose company set up by general practice in Sheffield toprovide support in delivering world class primary care. We deliver a wide rangeof high-quality at-scale services including initiatives which are leading theway for change nationally. PCS exist to create services which make the health and care systemwork better for everyone. To do that we are focussed on bringing more servicescloser to the places people live, improving the quality of care, and breakingdown the barriers between different types of services.

ThePCS Research Office was formed in 2019 and delivers research projects inprimary care which aim to improve patient outcomes. We have expertise in contracts, human resources,and research finance, and we work in partnership with other organisations inSheffield to ensure that research is delivered efficiently and effectively. PrimaryCare Sheffield currently expanding its research programmes. This is anexciting post which is pivotal to improvingthe future quality of care so requires motivation and passion to deliverexcellent service within general practice.

Job description

Job responsibilities

Asa Clinical Trials Assistant, your main duties will include:

1. Clinical Duties

Providea safe environment for staff and service users having due regard to legislativeand study procedure requirements.

Contributeto the equity of care for all individuals.

Assistthe clinical research team in the delivery of planned clinical researchactivities and working to evidence-based care.

Prepareand collate relevant documentation and equipment for each study visit includingsource data forms, questionnaires, investigation request forms, blood/tissuecollection equipment etc.

Instigate emergency procedures whereappropriate.

Be able to support patients and carers duringrecruitment and participation in studies.

Administerquestionnaires/diaries/ to trial participants, providing clear instructions andoversight with appropriate supervision This may involve conducting telephoneassessments or seeing patients/participants in a clinical environment.

Undertakedelegated tasks without direct supervision where/when appropriate. This mayrequire the use of observational/analytical skills to monitor the health and well-beingof participants. This will include taking and recording of vital observations( blood pressure, heart rate, respirations. temperature), physical measurements( measuring waist circumference, weight), urinalysis and obtaining bloodsamples. In addition, they may also be required to perform other tests andprocedures commensurate with the role.

Workcollaboratively with other healthcare professionals and agencies to deliver ahigh standard of care.

Beaware of the health and safety issues regarding the handling/exposure to bodilyfluids when caring for participants.

Ensure any concerns regarding the patients arereferred to appropriate clinical colleagues at the earliest opportunity.

Undertake all such reasonable other duties asmay be required as part of the role.

Use appropriate information to make timely andeffective decisions about clinical research participants.

Obtain, process and transmit samples relatedto clinical research activities to the appropriate area.

Participatein the use of information and technology needed for the delivery of clinicalresearch activities.

Provideinformation in a form that meets the understanding of the receiver at alllevels.

Useoral, written, or computerised information that facilitates research activity followingstandard operational procedures and study procedures.

Completedocumentation following organisational policy and procedures

2. Professional Duties

Impartplans and instructions clearly and effectively

Establishclear lines of communication at all levels

Communicaterelevant and factual information to participants and carers, using sensitivityand tact.

Contributeto the understanding of patients in situations of communication difficulties.

Alwaysmaintain patient and professional confidentiality.

Contributeto a working culture which is open to change, new ideas, concepts, andinnovation whilst reflecting organisational strategy and values.

Willingto develop new skills and participate in training and development of new teammembers, acting as mentor when required, in line with service development.

Beflexible, motivated and will have a keen interest in pursuing a wider knowledgeand understanding of clinical research.

Participatethrough appraisal in matching organisational aims with personal objectives andsupporting research staff within their own area of responsibility to do thesame.

Attend and contribute to meetings held by theteam and the organisation.

3. Performance & Finance Duties

Assistthe research nurses to log activities within the appropriate reporting systemsto allow invoices to be generated accordingly.

4. General Duties

Participatein regular supervision.

Completeall mandatory and essential training as per organisational and departmentalguidelines/policies.

Participate annually identifying, developing,and agreeing your own development plan with your Line Manager using the theorganisational appraisal.process

Complywith all organisational policies, procedures, and protocols.

Seekadvice and support from Line Manager whenever necessary.

Maintainprofessional conduct including appearance at all times.

Ensure maintenance of ProfessionalRegistration/Qualifications (eg GCP)

Thepost-holder may be required to undertake any other duties reasonably fallingwithin the grade of this post ( taking and circulation of meeting minutes,creating study proformas, etc) .

Note : This job description is not exhaustive and may be added to orchanged to from time to timefollowing discussion andconsultation with the post holder and line manager

Person Specification

Experience

Essential

Previous experience within a healthcare setting (, healthcare assistant/phlebotomist) OR Proven, relevant experience as an administrator working within busy office environments, dealing with people at all levels and contributing in a positive, proactive manner Evidence of comprehensive administrative experience including the use of Microsoft Office software (including Word, Excel, and Outlook) Proven experience of working independently on projects/tasks, ability to work as a team member & on own initiative Evidence of excellent communication with patients, service users or general public, and the ability to demonstrate a professional and compassionate manner

Desirable

Experience in extracting and inputting data Previous experience working on clinical trials Supporting clinical teams with the co-ordination of projects or aspects of patient care Evidence of the ability to streamline /improve processes

Qualifications

Essential

Good standard of education to GCSE level, this must include GCSE English, Science and Maths grade 9-4 (A*-C) or equivalent NVQ Level 3 qualification in Administration, Health or Science or equivalent experience in the same areas OR Health Specific NVQ level 2 for Health Care applicants Evidence of the uptake of training opportunities relevant to previous roles Willingness to undertake any training or development relevant to the role

Desirable

Competent in phlebotomy & performing general health observations eg Height, Weight, ECG Good clinical practice certificate (GCP)

Knowledge and Skills

Essential

Flexibility to ensure achievement of objectives within constantly changing environments Problem solving skills Meticulous attention to detail Well- developed organisational skills and ability to multi-task, working accurately, particularly when dealing with conflicting deadlines & adapt to changing circumstances Professional attitude to work Diplomatic and calm under pressure Participate in and contribute to team discussions IT skills and a willing to learn new clinical research systems Demonstrate a commitment to a caring profession Good Literacy skills & attention to detail Able to prioritise and manage time effectively Ability to support and educate colleagues, patients and carers

Desirable

Insight into the role and responsibilities of the post Understanding of clinical research & research processes

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