Operations Assistant (Clinical Trials)

Comprehensive Cancer Centre

London, Guy's Campus

Overview

  • Posted on: 03rd Nov 2021
  • Salary: £29,127 - £32,256 per annum, including London Weighting Allowance
  • REF: 036185
  • Closes: 24th November 2021
  • Contract Type: Fixed-Term/Contract
  • Hours: Full Time

Job description

Acting as patient and participant advocate at all times, the post holder will be expected to co-ordinate research clinics and organise study related care. They will identify strategies to find and assist in the enrolment of research participants. The post-holder will perform a range of clinical assessments in line with accepted standards of practice. They will communicate effectively with the study and clinical teams to ensure good participant experience and adherence to study protocols. The post holder will be responsible for case report form completion, site file management and maintenance of databases. They will be responsible for ordering study supplies. The post holder will ensure the well-being of participants by adhering to relevant regulations and local Standard Operating Procedures (SOPs) including Good Clinical Practice (GCP), Medicines for Human Use (Clinical Trials) Regulations, Research Governance Framework for Health and Social Care and the Human Tissue Act.

This post will be offered on an a fixed-term contract for 1 year

This is a full-time post – 100% full time equivalent

Key responsibilities

  • Provide excellent customer care skills to ensure patients and participants come first.
  • Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the study protocol is adhered to at all times.
  • Co-ordinate research clinics and co-ordinate a portfolio of studies in conjunction with team members. This involves planning and organising clinical study related care or tests in accordance with approved study protocols or departmental standard operating procedures.
  • Establish strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. Gain permissions for research contacts.
  • For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol.
  • Organise appointments and conduct telephone follow-up calls as required.
  • Report any adverse events or health concerns which occur whilst the participant is taking part in the study, to an appropriate doctor or nurse in a timely manner and to the appropriate principal or co-investigator.
  • Perform and record a range of clinical assessments in line with personal competencies and as stipulated in approved study protocols including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
  • Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals.
  • Responsible for ensuring safe and appropriate storage, shipment and documentation of specimens.
  • Keep up to date with current practice for phlebotomy and venepuncture.
  • Provide ongoing support to the participant and carer whilst participating in the clinical study.
  • Communicate on a regular basis with senior medical staff, nursing, pharmacy, radiology, and pathology and laboratory staff.
  • Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication.
  • Take responsibility for ensuring own knowledge of amendments and updates to studies you work on and assist the research team in ensuring that information relating to updates in the study protocols and guidelines are disseminated to key areas and personnel.
  • Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding.
  • Communicate with external study coordinators and sponsor representatives, nationally and internationally.
  • Send GP letters or other trial related material to relevant parties.
  • Arrange, attend and record minutes for research and other relevant departmental meeting.
  • Assist with the organisation and set up of selection and initiation and investigator meetings for studies.
  • Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required.
  • Update participant study and medical records to accurately document study related activity and procedures.
  • Administration and maintenance of trial site files in coordination with sponsor representatives.
  • Ensure the confidentiality of verbal, written and computerised information.
  • Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patient’s medical notes and study file is transcribed accurately.
  • Responsible for the maintenance of Investigator Site Files.
  • Create databases, validate and maintain them and ensure their security and compliance with the data protection act.
  • Update and maintain centralised patient database.
  • Deal effectively with queries relating to data and information in a timely and efficient manner.
  • Assist in the creation and maintenance of good office systems for the smooth running of the service.
  • Organise and prepare documentation for monitoring visits.
  • Provide timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
  • Escalate any issues regarding data collection to the appropriate personnel.
  • Assist sponsor and/or R&D with relevant essential documents at set up of a study.
  • Assist in archiving processes for closed studies within the team.
  • Provide advice and training to colleagues as relevant to your role.
  • Supervise, train or mentor new or more junior staff as required.
  • Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
  • Act in accordance with the Health Education England (HEE) Care Certificate framework standards at all times.
  • Undertake an Individual Performance Review annually with your Line Manager.
  • Assist other members of the multidisciplinary team as required with all aspects of study delivery.
  • Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.
  • Co-ordinate and supervise housekeeping duties and ordering of study supplies as requested.
  • Responsibly assist in the management the control of equipment, resources and stock through the adherence of research policies and study budgets.
  • Ensure own actions help to maintain quality.
  • To work as a member of a multi-disciplinary team
  • Work collaboratively with colleagues across R&D, NIHR Guy’s and St Thomas’ BRC and wider Trust to facilitate the achievement of objectives and shared learning.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience

Essential criteria

1. NVQ level 4 or equivalent qualification or qualified to NVQ3 or equivalent plus significant previous experience

2. Experience of working in a healthcare or clinical research role with patient/public communication/ coordination duties OR biomedical degree and experience working in a public facing role

3. Experience of working in a team

4. Experience using databases

5. Excellent interpersonal skills

6. Ability to communicate well (written and verbally), with clear and legible handwriting

7. Able to work in a multidisciplinary team and on own initiative

8. Knowledge of medical terminology

9. Ability to co-ordinate collection of data to agreed timescales

10. Ability to co-ordinate participant visits with multidisciplinary team

11. Ability to understand and comply with research protocols and departmental procedures and report difficulties and exceptions to senior staff

12. Ability to manage priorities under pressure

13. Able to conduct clinical tasks such as blood pressure, temperature, pulse and respiratory observations.

14. Ability to develop skills required by research protocols for example phlebotomy and sample collection and basic laboratory skills

15. Ability to acquire basic laboratory skills.

Desirable criteria

1. Evidence of education related to clinical research

2. Good Clinical Practice training

3. Experience performing basic clinical tasks such as clinical observations (height, weight, blood pressure, pulse, temperature)

4. Experience of caring for patients/participants in a professional setting.

5. Experience of working on clinical trials of drugs, therapies or interventions.

6. Knowledge of mandatory standards for clinical research conduct (including GCP, UK Policy framework for Health and Social Care research, data protection)

7. Able to collect blood samples via venepuncture

8. Good knowledge of medical and clinical terminology

Further information

This post is subject to Disclosure and Barring Service and Occupational Health clearance.

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