Job description

Job responsibilities

Study set-up responsibilities: feasibility support, site set-up activities, delegation logs, essential documents/Investigator Site File (ISF) set-up, Site Initiation Visits (SIV) support, creating/reviewing local processes/SOPs.

Monitoring/oversight readiness: explicit responsibility for supporting monitoring visits, audits, inspections, addressing findings/Corrective and Preventive Actions, and maintaining inspection-ready Trial Master File (TMF)/ISF.

To interact appropriately with research participants, service users, their carers and relatives, with the ability to convey the goals of the research in a friendly manner, ensuring that any research undertaken safeguards the well-being of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006.

To support the recruitment of participants to research studies in mental health through liaison with local research networks and clinical teams.

To assist in obtaining valid informed consent to take part in research studies, providing complex verbal and written information in the process of explaining study involvement.

To collect research data through standardised assessment measures completed with participants

To maintain Trust records and any trial databases and, ensuring entries are complete, accurate and up to date in accordance with the Trust policies, the protocol and Good Clinical Practice guidelines.

Person Specification

Qualifications

Essential

• BSc Degree in health or social care or Psychology degree. (A)
• Completion of GCP training in the last 2 years (A)
• Clinical Research Practitioner Registration or working towards Registration (A)

Desirable

• Higher degree/formal study of research design and methods in clinical or social settings (A)

Experience

Essential

• Relevant research experience. (A/I)
• Understanding of the needs of mental health service users who may wish to be involved in research. (A/I)
• Previous experience of working as part of a research team delivering NIHR portfolio studies and commercial clinical trials and CTIMP (Clinical Trials of Investigational Medicinal Products. (A/I)
• Knowledge of, and clinical experience within, mental health services. (A/I)
• Experience of data management and working in accordance with study protocols, including lone working where required. (A/I)
• Project management experience. (A/I)
• Experience of administering psychometric scales (A)
• Ability to engage, influence, and motivate individuals to participate in mental health research. (A/I)

Desirable

• Experience of working within an NHS environment with direct contact with mental health service users (typically 1+ year). (A/I)
• Experience of working within a research delivery team supporting commercial clinical trials and NIHR portfolio studies. (A/I)
• Experience of participating in research projects involving service users and staff within a Mental Health Setting. (A/I)
• Current or recent experience of working with people with serious mental illness. (A)
• Phlebotomy skills, or willingness to undertake training. (A)
• Experience of conducting patient and public involvement (PPI) and public engagement activities. (A/I)

Knowledge/Skills

Essential

• Experience of using the CONSORT guidelines for reporting clinical trials. (A/I)
• Experience of using the Intervention Fidelity (IF) framework for randomised controlled trials. (A/I)
• Excellent communication and interpersonal skills. (A/I)
• Highly motivated, with the ability to work both independently and as part of a team. (A/I)
• Excellent organisational skills, with the ability to prioritise workload effectively. (A/I)
• Knowledge of research methods and basic statistical procedures. (A/I)
• Experience with electronic systems (e.g., Electronic Data Capture (EDC)/electronic Case Report Form (eCRF), Clinical Trial Management System (CTMS)) and competence in standard IT packages (e.g. Microsoft Word, Excel) and general data entry. (A/I)
• Ability to establish and maintain accurate documentation and record-keeping systems. (A/I)

Desirable

• Commitment to obtain underpinning knowledge through work-based learning (A/I)

Other

Essential

• Enthusiastic and committed to supporting organisational change and contributing to research and strategic ambitions. (A/I)
• Able to work in a flexible, mobile/agile manner across sites. (A/I)
• Demonstrates honesty, integrity, and transparency in all aspects of work. (A/I)
• Able and willing to travel independently Trust-wide. (A/I)
• Demonstrates emotional resilience and the ability to manage a varied and demanding workload. (A/I)
• Proactive and positive "can-do" attitude, with a focus on improving recruitment and reducing barriers to participation in research. (A/I)

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

South London and Maudsley NHS Foundation Trust

Address

South London and Maudsley NHS Foundation Trust

Maudsley Hospital

London

SE5 8AZ

United Kingdom

Employer's website

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