Clinical Research Practitioner in Lowestoft

East Coast Community Health Care CIC is developing their Research and Development team. We are seeking a Clinical Research Practitioner to support the delivery of research in the community. This is a new role within ECCH. The successful candidate will become an integral part of the Quality team, with a focus on supporting the clinical teams to deliver research activity within the organisation and wider community.

This post would suit an individual with recent experience of clinical research in NHS/Academic/Pharmaceutical setting. This varied role would suit someone who has a flexible approach to working, is diligent, able to use their own initiative, likes working with other clinical teams and external partners and has an understanding of clinical research delivery and associated regulation. There will be opportunities to promote research with clinical teams, patients and our wider community. An interest in research and evidence-based practice is essential. There is flexibility in how the hours are worked across the working week. This post is offered between 30 and 37.5 hours per week. There will be no requirement to work Weekends or Bank Holidays.

Main duties of the job include:

• To ensure that all study protocols, standard operating procedures, research governance, and good clinical practice guidelines are always adhered to.
• Ensure that all study documentation is maintained and stored confidentially.
• Support the study team in ensuring all reporting to regulatory bodies, and Research Networks (if applicable), is done in a timely manner.
• Support the study team to ensure that all research study equipment used is appropriately checked and calibrated (if applicable) with supporting documentation retained.
• Liaise with ICB Research and Development Team and sponsors if applicable to ensure all arrangements for research governance for each study are in place.
• Assist in the completion of participant assessments in accordance with study protocols, where appropriate within scope of practice and specified within study delegation log.
• Appropriately document and report all serious adverse events and incidents.
• Able to take informed consent in line with study protocols.
• Utilise computer skills for producing reports, spreadsheets and correspondence.
• Accurately transcribe and enter data into databases as required.
• Assist with the development and management of promotional materials such as newsletters and websites.
• Manage multiple concurrent projects and research sites, requiring flexibility and adjustment according to demand.
• Communicate complex, sensitive information with a range of staff internally and externally within partner organisations.
• Adhere to processes and procedures for ensuring participant confidentiality in compliance with the Data Protection Act and Caldicott regulations.
• Interpret research project protocols, convey and handle statistical information with an ability to communicate information to clinical teams in an understandable format.

All roles within East Coast Community Healthcare CIC (ECCH) require staff to demonstrate our Values and Signature Behaviours in the care and service they provide to patients, service users, stakeholders and colleagues. Our Values outline the core behaviours that we can all achieve and are summarised as an acronym within the word 'CARE'. These stand for: Compassion, Action, Respect and Everyone.

Qualifications required include:

• Undergraduate degree or equivalent theoretical knowledge in health-related subject.
• Registered Clinical Research Practitioner (CRP- Academy for Health Care Scientists), or willingness to undertake accreditation.
• Good Clinical Practice (GCP) certificate (or commitment to undertake).
• Care Certificate (or commitment to undertake).
• Evidence of continuing professional development.

Experience required includes:

• Recent clinical research experience in NHS/academic/pharmaceutical setting.
• Previous research data management experience, including data collection, entry and database set up.
• Previous experience of the clinical research processes, GCP and research governance.
• Previous NHS or research administration experience and good understanding of medical terminology.

Skills and knowledge required include:

• Knowledge of clinical research, processes, governance and clinical trials regulations.
• Demonstrated ability in using Microsoft Office and related packages, including databases and spreadsheets.
• Ability to develop clinical skills required by the research protocols within scope of practice.
• Good report writing skills with a focus on accuracy and attention to detail.
• Excellent organisational skills with the ability to work to deadlines and targets.
• Ability to promote the participation of clinical research within clinical teams and wider community.

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 to check for any previous criminal convictions.