Research Assistant (EF:100)

Job description

Job responsibilities

DUTIES and KEY RESPONSIBILITY

1. CLINICAL

Work autonomously to manage and coordinate own study portfolio within the designated areas of responsibility, whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and professionals to ensure service delivery.

Be responsible for consenting to non-commercial Registry studies and other non-commercial Investigator-led studies.

Be responsible for the whole patient recruitment process from selection to screening and from randomisation to the scheduling of study visits. Evaluate patient eligibility for the trial, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to the research protocol.

Ensure patients are fully informed prior to entry into the clinical research programme and play a key role in eliciting informed consent to participate. To provide ongoing advice and information to patients with regards to their participation in clinical research in order to facilitate effective informed consent.

Act as a resource and support to patients and their relatives, explaining practical aspects of the trial, assisting and supporting local nursing teams when necessary.

Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that the trial is conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate.

Coordinate the collection of any biological samples required as part of the clinical trial and ensure safe and appropriate storage of specimens. Monitoring and recording daily freezer and fridge temperatures and reporting any temperature excursions to the Clinical Research Manager/Matron.

Ensure the safe administration of the investigational medicinal product (IMP), have in-depth knowledge of the legal requirements of the individual Trusts clinical trial pharmacovigilance and pharmacovigilance policies. Report any adverse events and reactions in accordance with this policy and the trial protocol. Report any serious adverse events within 24 hours of knowledge of the event, to the sponsors. (For non-commercial studies please use the appropriate SAE forms supplied by the host sites. For KCH & GSTT-sponsored non-commercial studies, please use KHPCTO forms).

Maintain clear and accurate source data and other records; ensure a high level of accuracy when transcribing data onto electronic or paper case report forms; create and design database as required for patient and staff records.

Assist the PIs in liaising with the KHPCTO and R&D Office relating to submission of the study for regulatory approval and Trust Management approval. Assist in completing submissions to the Health Research Authority (HRA) as required.

Perform tasks requiring highly developed clinical skills including phlebotomy, cannulation and keep up to date with current practices for cannulation, phlebotomy etc,

To oversee the routine maintenance and servicing of research equipment. To ensure that all research equipment is calibrated annually and that the calibration certificates are filed in the Equipment File. Ensure that the freezers are maintained in good conditions. Perform essential tasks to prevent build-up of ice around the frame of the freezer doors.

Liaise with the Research Nurses regarding administration of trial drugs to your study patients.

Be responsible for the accountability of the oral medication used by your study patients.

2. MANAGEMENT:

To act as clinical supervisor to junior research staff within the Department and individual area of responsibility and act as a role model for excellence in clinical research environment.

To be responsible for reporting on In-Phase any adverse incident/near misses in relation to any of your non-commercial and Investigator-led trials, as supervised by a Senior Research Nurse.

To facilitate and maintain effective communication within the clinical and research teams.

To responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trial budgets.

To assist in training new starters.

To ensure that investigators GCP certificates and CVs are valid at all times.

3. EDUCATION / TRAINING:

Ensure mandatory clinical research trials training is undertaken and updated as required.

Ensure the Trusts mandatory training is undertaken and completed prior to annual appraisals.

To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness.

To be trained on all Health Care Assistant (HCA) courses held by the Trust.

To ensure that the ICH-GCP certificate is valid at all times and to revalidate it at 2 yearly refresher courses.

To ensure that your IATA and HTA & Consent training is revalidated every 2 years.

• To be trained on the Sponsors systems for your studies so as to be able to receive access.

4. PROFESSIONAL:

You will be accountable for your own professional actions, acting within clearly defined policies/procedures and codes of conduct and Trust policy.

• To observe the rules, policies, procedures, and standards of Kings College Hospital NHS Foundation Trust and the other NHS Trusts, together with all relevant statutory and professional obligations.

To undertake a Trust appraisal annually to identify organisational and professional objectives and developmental needs.

• To keep up to date with departmental, Trust, NIHR, RDN, academic developments for the management of clinical research, ensuring timely and effective implementation of changes.

To attend courses as deemed relevant, including mandatory training, and to attend meetings and conferences as appropriate.

• To be responsible, with management support, for your own personal development and to actively contribute to the development of junior colleagues.

5. GENERAL

The post holder has a general duty of care for their own health, safety and well-being and that of work colleagues, visitors and patients within the hospitals, in addition to any specific risk management or clinical governance accountabilities associated with this post.

To observe and maintain strict confidentiality of personal information relating to patients and staff.

To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.

Person Specification

Essential and Desirable

Essential

• Educated to A Level
• ICH-GCP
• HTA and Consent
• IATA
• Significant experience in the research setting as a Band 3
• Experience in liaising with study monitors and sponsors
• Experience in maintaining study data bases
• Experience in reporting SAEs within the 24-hour deadline
• Good communication and interpersonal skills
• Computer literacy & competence in standard pc packages
• Venepuncture & cannulation
• A good understanding of research governance and ethics
• Knowledge of NHS/clinical setting
• Awareness of the need for discretion and confidentiality
• Study set-up, delivery, completion
• Ability to work under pressure
• Ability to work independently and as part of a team
• Ability to impart study information to patients, relatives and carers, with different levels of understanding
• Ability to enter data onto sponsors' EDC systems accurately and in a timely manner
• Ability to interact sensitively and professionally with clinical staff and patients
• Adaptable and Flexible
• Punctual and dependable
• Willing to learn new skills
• Maintains a professional image
• Motivated and enthusiastic

Desirable

• Degree Level or Equivalent
• Some experience of working with Renal, Diabetic, Urology, Endocrine or Obesity patients
• Safety Reporting via In-Phase in a timely manner
• Research Invoicing

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

King's College Hospital NHS Foundation Trust

Address

Kings College Hospital NHS Foundation Trust

Denmark Hill

LONDON

SE5 9RS

Employer's website

https://www.kch.nhs.uk/ (Opens in a new tab)