Clinical Research Practitioner - Vaccine and Trials team

Job description

Job responsibilities

Clinical and Communication 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 clinical trial protocol is adhered to at all times.
• Lead on a portfolio of trials and coordinate participation. This requires liaising with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol, paying particular attention to accurate data collection and dissemination and version control of essential documentation.
• Devise, implement and evaluate 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 and facilitate participant appointments and follow-up phone calls.
• Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
• Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or co-investigator.
• Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate.
• Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol
• Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples.
• Provide ongoing support to the participant and carer whilst participating in the clinical study.
• 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 effectively and efficiently specialised advice pertaining to research protocols to members of the multidisciplinary team.
• Engage effectively 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.
• Communicate with external study coordinators and sponsor representatives, nationally and internationally.
• Attend and participate in departmental meetings and help promote new ideas and methods and assist in their implementation.
• Attend and participate in multidisciplinary team meetings.
• Arrange, attend and record minutes for research and other relevant departmental meeting.
• Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required.

Information and data management

Update participant study and medical records to accurately document study related activity and procedures.

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 participants medical notes and study file is transcribed accurately.

Responsible for the maintenance of the Investigator Site Files.

Aid with local study set up to ensure all applicable documents are ready to use once relevant approvals are received. Organise study set up visits, involving all relevant departments.

Create databases, validate and maintain them and ensure their security and compliance with the data protection act.

Update and maintain centralised database.

Responsible for ensuring that all data queries are dealt with in a timely and efficient manner.

Assist in the creation and maintenance of good office systems for the smooth running of the service.

Plan, prepare documentation and participate in audit and monitoring visits.

Implement strategies to ensure full and accurate data-set for all study participants.

Process amendments according to standard operating procedure as received in a timely manner.

Collate data and compile reports for the Clinical Lead, Research Managers and commercial sponsors as required.

Provide timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.

Management and leadership

Provide advice and training to colleagues as relevant to your role.

Supervise, train or mentor new or more junior staff as required.

Act as a role model, giving guidance, counselling and support to new and junior staff.

Actively contribute to the teaching programme within the department.

Education and Professional development

Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.

To maintain an up to date knowledge relevant to the specialty and research.

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.

Maintain a record to reflect any training carried out pertaining to the post.

Other responsibilities

Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.

Responsibly manage the control of equipment, resources and stock.

Actively seek to develop the role to take account of changing requirements of the service.

Ensure own actions help to maintain quality.

To work as a member of a multi-disciplinary team.

Work collaboratively with colleagues across R&Dand wider GSTT to facilitate the achievement of objectives and shared learning.

Local Area Variation to Core Job Description

This job description forms the basis of the Band 5 Clinical Research Practitioner duties. You should be aware that there might be other specific assigned tasks relevant to a particular area of work.

Full time contracts are based on a 37.5 hour working week. Exact work patterns and hours will be agreed between the post holder, their Line Manager and management Team based on the needs of participants, the service and the requirements of study specific protocols. This may require working outside of 08:00-08:00 on weekdays and/or weekends.

Person Specification

Skills/Knowledge/ Ability

Essential

• Able to conduct clinical tasks such as blood pressure, temperature, pulse and respiratory observations.
• Able to collect blood samples via venepuncture.
• Ability to acquire skills in cannulation and serial sampling.
• Ability to acquire skills in processing biologic samples according to protocols.
• IT skills, specifically in database management, Microsoft, Excel and eRecord

Desirable

• Presentation and teaching skills
• Proficient in cannulation and serial sampling.
• Proficient in conducting ECG.
• Ability to manage priorities for others

Previous experience

Essential

• Experience of working in a relevant research setting
• Experience of working on own and in multidisciplinary team
• Experience of working in a patient/participant facing role with clinical duties.
• Experience of working on interventional studies or complex/ large scale observational studies'

Desirable

• Experience with electronic case report forms and computer packages
• Experience supervising others
• Experience of working on clinical trials of drugs, therapies or interventions.

Qualifications/ Education

Essential

• Degree in life sciences or related field or equivalent theoretical knowledge
• Evidence of continuing professional development
• GCP certification
• Commitment to work towards joining the AHCS accredited CRP register

Desirable

• Relevant course to clinical area
• Member of NIHR CRP directory

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

Guy's and St Thomas' NHS Foundation Trust

Address

St Thomas' Hospital, Clinical Research Facility (CRF), North Wing, 4th floor

Westminster Bridge

London

SE17EH

Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)