Clinical Studies Development Officer

Job responsibilities

Promotion of the CRN East Midlands Research Site Initiative (RSI) Scheme, and contribution to the overall growth of research conducted in Health, Social and Primary Care in your locality.

Performance management of the RSI sites against key performance indicators for the financial year Promotion of Research within Primary Care, this may include presentations to healthcare professionals/ providers and the general public.Supporting research nave Health, Social and Primary Care sites in becoming research active, this may include assisting with the delivery of research training and education Maintain an understanding of the changing landscape in Health, Social and Primary Care, with specific focus on Primary Care Networks (PCNs) Work with the CRN Study Support Service to support the facilitation of study set-up and delivery in Primary Care settings, the post holder will be expected to collaborate effectively, and engage with a diverse range of personnel including: staff members from primary care organisations, R&D staff, commercial/non-commercial sponsoring and funding organisations, chief/principle investigators (academic and NHS), heads of department, directorate leads, and staff from other Trusts.

Utilising and updating the Local Performance Management System Edge, in the performance management of Primary Care sites and studies. Promoting and utlising the CRN East Midlands Primary Care Research Website and supporting sites to access and use this. Assisting sites in keeping site Research Activity Records up to date. To develop an understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance.To work alongside Health, Social and Primary Care sites, ensuring staff delivering research at the sites have in date ICH GCP and Informed Consent (where appropriate) training.

The following duties may be undertaken by the post holder, at times when there is a requirement for additional clinical delivery support for studies taking place in the region:

To identify patients suitable for entry into clinical trials and research studies, this may include attending clinics and multidisciplinary team meetings, reviewing medical notes and inclusion/exclusion criteria.

To ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate (i.e. informed consent)

To attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research projects.

Where appropriate, to take consent from patients/participants to enter research studies.

To take relevant patient samples for clinical trials; such as blood samples, tocentrifuge and separate serum, package and dispatch as per defined protocols, where appropriate.

Observe patients and monitor treatment toxicity/side effects; escalating findings accordingly.

Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes.

Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner.

To ensure safe and appropriate storage of specimens, in accordance with the trial protocol and in conjunction with specialist teams.

To record and report any adverse events and serious adverse events according to trial protocol and local procedures.

Develops and maintains constructive relationships whilst reconciling or resolving conflict.

Be responsible for managing their own workload, working to competing deadlines, working against performance targets and resolving problems. Takes responsibility for implementing decisions and plans owned by the team.

Maintain efficient and effective communication with Primary Care Team Leader on issues related to staff conduct within research trials andimpact on participant care.

To be flexible in their approach to work as the role may require flexibility in terms of timing e.g. for specific treatments.

In accordance with professional codes, maintain own professional development and competence to practice.

Undertake data entry and assure its accuracy and timeliness to study records in both LPMS (Edge) and national (CPMS) databases and support their maintenance.

Create of reports on study setup and patient recruitment, using the Open Data Platform and other NIHR Systems and use these to review data quality and to support performance monitoring and management of studies.

Provide CRN assistance to audits, monitoring visits or regulatory inspections.

Take responsibility for the maintenance of confidentiality, security and integrity of information relating to patients, staff and other health service members in the NHS organisation and IHSP setting of the Study Support Service.

Provide research support and training for individual trials being conducted within the network region, it is expected that this will involve working on more than one project at any time and in more than one clinical specialty as appropriate.

Develop training guides as required to support researchers and colleagues in understanding aspects of the Primary Care Research Delivery Team. Ensure that training pertinent to the role is up to date e.g. ICH-GCP, Edge, as well as mandatory training as directed to develop/maintain skills and knowledge.

Be flexible in the approach taken to work.

Be accountable for all tasks within the scope of the role and to be aware of developmental needs/limitations while providing support to others. As the post will cover a number of NHS Trusts/partner organisations, there will be a requirement to travel around the geographical area covered by the CRN: East Midlands on a frequent basis.

Experience

Essential

• Awareness of current national systems and structures for the approval, management and monitoring of clinical research in the NHS
• Experience in developing, implementing and following standard procedures.
• Experience of using spread- sheets, databases and IT systems.
• A good understanding of research design and methodology.
• Experience of working on / coordinating NIHR portfolio research studies within the NHS, both commercial and non-commercial research.
• Knowledge of the clinical trial lifecycle including experience of the set up and performance management of clinical research studies within the NHS.
• Proven record of planning, organisational, change management and administration skills.

Desirable

• Experience of working in a Primary Care setting.
• Research qualification (e.g. ICH-GCP/EU Directives).
• Experience of Google Suite and Project Management Systems.
• Experience of using a Local Portfolio Management System (LPMS e.g. Edge) and the Central Portfolio Management System (CPMS eg. ODP).
• Knowledge of NIHR industry costing template and/or Department of Health AcoRD guidance.
• Experience of the clinical care of patients enrolled in research studies.
• Experience in Leading a Team
• Line Management Experience

Training & Qualifications

Essential

• Educated to Degree level or equivalent level of experience
• Willing to undertake necessary training relevant to the post.
• Willing to undertake and complete a competency-based package.

Desirable

• Research qualification (e.g. ICH-GCP/EU Directives)
• Project Management Training

Communication & relationship skills

Essential

• Ability to build working relationships and gain the respect of others.
• Ability to work well in a team and to work independently as required.
• Highly motivated, with the ability to influence and inspire others
• Ability to manage challenging behaviour and difficult situations in a diplomatic and professional manner.
• Ability to work with sensitivity and tact sometimes with sensitive or contentious information
• Able to manage difficult and distressing situations effectively

Desirable

• Ability to persuade and positively influence other team members and work colleagues
• Flexible approach to working and a desire to develop knowledge.

Analytical & Judgement skills

Essential

• Ability to problem solve and negotiate
• Ability to plan and prioritise own workload.
• Possess attention to detail.
• Ability to read and interpret complex documents including research protocols.
• Ability to accurately interpret and present data in appropriate formats
• Ability to process and collate information quickly and to be able to make well informed judgements in a timely manner.

Desirable

• Able to analyse problems and initiate appropriate solutions effectively.
• Able to use judgement and initiative to provide information and support.
• Good understanding of the performance measures applied in the NHS.

Planning & organisation skills

Essential

• Excellent planning and organisational skills, with the ability to prioritise and work to multiple deadlines.
• Ability to work to local and national deadlines, objectives and targets.
• Managing multiple projects, diaries and appointments, resolving conflicting schedules

Desirable

• Ability to work to deadlines when completing study budgets and contract negotiations and other designated timelines.
• Ability to identify and establish agreed workload/tasks with study site teams, Industry sponsors/contract research organisations, CRN AND LCRN team members and other NHS organisation contacts.

Physical Skills

Essential

• Ability to travel across the East Midlands region on a regular basis.
• Desk based, some light lifting (e.g. stationery) and travelling. - Frequent requirement for concentration.
• Aspects of clinical work in clinical Settings

Equality, Diversity & Inclusion

Essential

• Able to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
• All staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others

Other requirements specific to the role

Essential

• Engages with and promotes continuous improvement projects.
• Flexible approach to working and a desire to develop knowledge
• Demonstrates enthusiasm
• Professional manner.
• Access to own transport and able to travel across the locality and further afield, on occasion.

Desirable

• Clinical skills including venepuncture

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).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).