Clinical Trials Assistant (Experienced)

Job description

Job responsibilities

As a Clinical Trials Assistant-experienced, your main duties will include:

Clinical Duties

• Provide a safe environment for staff and service users having due regard to legislative and study procedure requirements.

• Contribute to the equity of care for all individuals.

• Assist the research team in the delivery of planned clinical research activities, working to evidence-based care.

• Prepare and collate relevant documentation and equipment for each study visit, including source data forms, questionnaires, investigation request forms, blood/tissue collection equipment etc.

• Support participants and carers during recruitment and participation in studies.

• Administer questionnaires and diaries to trial participants, providing clear instructions and oversight with appropriate supervision. This may involve telephone assessments or face-to-face visits.

• Undertake delegated tasks without direct supervision where/when appropriate. This may require the use of observational/analytical skills to monitor the health and well-being of participants.

• Take and record vital observations e.g. blood pressure, heart rate, respirations, temperature, physical measurements e.g. measuring waist circumference, weight, performing urinalysis, obtain blood samples, centrifuge blood samples and manage and coordinate the packing and shipping of biological samples. In addition, they may also be required to perform other tests and procedures commensurate with the role.

• Work collaboratively with other healthcare professionals and agencies to deliver a high standard of care.

• Maintain awareness of the health and safety issues regarding the handling/exposure to bodily fluids when caring for participants.

• Understanding and adhering to infection control and cold-chain guidelines.

• Ensure any concerns regarding the patients are referred to appropriate clinical colleagues at the earliest opportunity.

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

• Use appropriate information to make timely and effective decisions about clinical research participants.

• Obtain, process and transport biological samples related to clinical research activities following the trial laboratory manual.

• Participate in the use of information and technology needed for the delivery of clinical research activities.

• Provide information in a form that meets the understanding of the receiver at all levels.

• Use oral, written, or computerised information that facilitates research activity following standard operational procedures and study procedures.

• Complete documentation following organisational policy and procedures.

• Support the receipt, storage, accountability and reconciliation of investigational medicinal products, in accordance with study Protocols, pharmacy manuals and local SOPs.

Professional Duties

• Impart plans and instructions clearly and effectively.

• Carry out administrative procedures in compliance with the principles of Good Clinical Practice and all regulatory legislation and local SOPs.

• Establish clear lines of communication at all levels.

• Communicate relevant and factual information to participants and carers, using sensitivity and tact.

• Contribute to the understanding of patients in situations of communication difficulties.

• Maintain patient and professional confidentiality at all times.

• Contribute to a working culture which is open to change, new ideas, concepts, and innovation whilst reflecting organisational strategy and values.

• Willing to develop new skills and participate in training and development of new team members, acting as mentor when required.

• Be flexible, motivated and will have a keen interest in pursuing a wider knowledge and understanding of clinical research in a primary care setting.

• Attend and contribute to meetings held by the team and the organisation.

• Support site monitoring activities including preparation for monitoring visits, responding to data queries and filing of follow-up documentation.

Performance & Finance Duties

• Assist the research team to log activities within the appropriate management reporting systems such as EDGE, to allow invoices to be generated accordingly.

• Complete invoices accurately at the required time intervals and ensuring payment is received.

General Duties

• Seek advice and support from the research team or line manager whenever necessary.

• Maintain professional conduct, including appearance at all times.

• Ensure maintenance of Professional Registration/Qualifications e.g.GCP.

• Maintain adequate participant records and ensure all relevant information is documented in the participants medical notes. Accurately document data collected into the case report forms.

• In association with the local clinical team, ensure that all adverse events are recorded and appropriately reported.

• Obtain any missing data and resolve queries with the clinical investigators and trial management office.

• Record and circulate meeting minutes.

• Create study proformas.

• Ensure study amendments are implemented in a timely manner.

• Maintain Investigator site files and essential study documentation in line with GCP and sponsor requirements.

The post-holder maybe required to undertake any other duties. This job description is not exhaustive and may be added to or changed to from time to time following discussion and consultation with the post holder and line manager.

Person Specification

Experience

Essential

• Previous experience as a clinical trial assistant within a research healthcare setting
• Evidence of comprehensive administrative experience including the use of Microsoft Office software (including Word, Excel, and Outlook).
• Self-motivated and proven experience of working independently on clinical trials, with the ability to work autonomously and as part of a team.
• Able to prioritise workload and manage time effectively.
• Meticulous attention to detail.
• Ability to facilitate the informed consent process in accordance of delegation and GCP requirements, ensuring that the participant (and carers/ family) fully understand the nature of the study; and ensure that the consent form is completed accurately and filled as required.
• Ability to accurately record clinical data and complete electronic case report e-CRF and paper case report forms, in a timely and efficient manner ensuring an audit trail is evident.
• Excellent communication skills and interpersonal skills (written and oral).
• Strong IT skills, particularly the set up and use of databases and willing to learn new clinical research management systems.
• Clear and polite telephone manner.
• Diplomatic and calm under pressure.
• Participate in and contribute to team discussions.
• Enthusiastic.
• Reliable.
• Professional attitude to work.
• Problem solving and analytical skills.
• Ability to understand and follow study protocols, schedules of events and laboratory policy and procedures.
• Flexibility to work outside of core office hours.
• Ability to support and educate colleagues, participants and carers.
• Knowledge of the requirements of clinical trials during their life cycle from set up to close out.
• Experience in clinical trial terminology and documentation.
• Ability to work independently and collaboratively in a fast-paced environment.

Desirable

• Experience working as a clinical trials assistant in a primary care setting.
• Experience of commercial and non-commercial costing templates and their completion.
• Evidence of the ability to streamline /improve processes.
• Evidence of autonomously managing a portfolio of research studies, demonstrating relevant experience and skill set
• Experience in taking meeting minutes
• Evidence of IATA, shipping biological sample training

Qualifications

Essential

• 2 - 5+ years of experience as a clinical trials assistant, clinical trials coordinator or similar role.
• Good standard of education to GCSE level, this must include GCSE English, Science and Maths grade 9-4 (A* - C) or equivalent.
• Evidence of the uptake of training opportunities relevant to previous research role.
• Show a willingness to undertake any training or development required to perform the role of experienced clinical trials assistant
• Qualified in Phlebotomy and in taking ECGs and clinical observations

Desirable

• Up to date GCP training
• Hands on experience of supporting multiple clinical trials simultaneously.
• Exposure to inspections or audits (MHRA etc)
• Familiarity with electronic systems such as iMedidata, Veeva, or similar platforms
• NVQ level 2 in health care.

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 (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Abbeywell Surgery

Address

Abbeywell Surgery

Great Well Drive

Romsey

Hampshire

SO517QN

Employer's website

https://www.abbeywellsurgery.co.uk/ (Opens in a new tab)