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Detailed job description and main responsibilities

Qualifications required

• Degree level education in Psychology or other health related subject, or equivalent relevant experience
• Knowledge and expertise regarding the mandatory standards regarding conduction/construction of clinical trials (to include GCP/Research Governance Framework/EU Directive/Data Protection Act)

Experience required

• Ability to coordinate collection of data to agreed timescales
• Experience of research in the NHS desirable
• Excellent computer skills

Suitable for someone who is highly motivated and passionate about providing high quality mental health research to people that use our services. Ability to work autonomously as well as part of the wider team is essential.

Key Responsibilities

 Clinical Monitoring:

• To assess and manage clinical information received via the Minder dashboard each shift
• To follow prescribed protocols and algorithms once information is received
• To communicate effectively with all stakeholders to pass on clinical data received
• To record all information in the electronic patient record (EPR) and any other system as necessary
• To maintain and build upon existing professional relationships with clinical and non-clinical Minder stakeholders to support effective working practices.
• To ensure the clinical effectiveness of clinical practice and of service functioning by undertaking audit, research and development activities relevant to Minder.
• Making sure protocols and governance are followed according to the Minder evaluation process.
• To contribute to the evaluation of the Minder System by participating in service-related audit, research and evaluation projects
• The post holder will respond professionally to all requests for information and assistance, using discretion as to appropriateness of requests and being aware of confidentiality and

Research:

Data Collection

• To collect participants’ data working to ICH GCP and research governance guidelines.
• To perform remote data entry on IT systems when required.
• To acquire additional clinical trial data from other departments and external organisations.
• Work alongside consultants and care coordinators to identify eligible participants for studies by screening consultant caseloads for example, to facilitate recruitment of participants to research studies
• Where possible, maximise participant retention in studies
• Ensure that participants are fully informed about research and ensure participants consent to research studies in accordance with legislation and taking into consideration the Mental Capacity Act
• Where required, support study delivery by undertaking research activities outlined in approved study protocol, including taking informed consent and administrating  cognitive assessments.
• Collect and maintain data and study documentation (including site files), and ensure that all data collected, stored and used is done so in compliance with relevant statutory instruments, national and local guidelines and regulations.

Clinical Trial Administration

• Adhere to Good Clinical Practice (ICH-GCP), Research Governance Framework, national and local practices and policies
• Provide written reports regarding the progress of the research to the research team
• Support the management team in the event of inspection from a regulatory and/or monitoring authority
• Participate in multi-disciplinary meetings and reviews
• The post holder will provide guidance and support for Principle Investigators, sharing knowledge of best practice and current legislation/guidance.
• Ensure all trials within the post holders remit, run within SABP, have received full ethical and Trust approval before being opened to recruitment
• Overseeing and assisting in the timely completion of Case Report Forms (CRFs) to reflect ongoing status of patients on trials.
• Responsible for reporting of any Serious Adverse Event (SAE) affecting patients enrolled into a clinical trial within required timeframe (usually 24 hours).
• Development and maintenance of trial site files.
• Provide timely information and reports to reflect recruitment of patients.
• As a member of the multi-disciplinary team, there will be involvement in the entire process of recruiting an individual participant to a clinical trial which will include: ensuring informed consent has been obtained, registration, randomisation, monitoring progress throughout treatment, relapse or treatment failure, treatment sequelae and follow up.
• Involvement in the planning, progress and management of clinical trials is a major job requirement and integral to the post.

Autonomous Working

• Prioritise work in an effective manner
• Work effectively with limited supervision
• Act independently and use own initiative to maintain collaborative research relationships with NHS, CRN, DRI and SABP staff.

Performance Management

• To receive regular supervision, both managerial and clinical, in accordance with SABP Trust policy guidelines
• To maintain and build on skills and competencies through annual appraisal and Personal Development Plans and attend training that takes account of evidence based practice and contributes to the team objectives. To undertake continuous professional development
• To work in accordance with all policies and procedures, including the support of equal opportunities and social inclusion.
• Take part in local, internal/external audits/inspections

This Job Description is an outline only and does not contain an exhaustive list of duties and there may be requirement to undertake additional responsibilities.  It may be amended by Surrey and Borders Partnership NHS Foundation Trust following discussion with the post holder.

KEY RELATIONSHIPS (This describes the types of roles you will be required to work with):     

Director of Innovation and Development

Associate Medical Director for R&D

R&D manager/Lead Research Nurse

The R&D Team

Clinical Research Officers and other staff

UK Dementia Research Institute (UK DRI)

Kent, Surrey and Sussex Comprehensive Local Research Network (KSS CRN)

UK Clinical Research Network