Job Summary
Ashton Medical Group hosts the NIHR Greater Manchester Commercial Research Delivery Centre Primary Care and is seeking an enthusiastic and motivated Research Delivery Nurse to support the delivery of a portfolio of late phase commercial clinical trials within primary care.

The post holder will work closely with investigators, research coordinators and the wider NIHR Greater Manchester Commercial Research Delivery Centre Primary Care team to deliver high quality research studies in accordance with study protocols, good clinical practice, regulatory requirements and local procedures.

The role involves participant recruitment, informed consent, clinical assessments, sample collection and processing, administration of investigational medicinal products where appropriate, study documentation, data collection and participant follow up.

The successful candidate will be based primarily at Ashton Medical Group but may be required to travel occasionally to partner sites across Greater Manchester.

Main Duties and Responsibilities

• Deliver research studies in accordance with approved protocols, standard operating procedures, good clinical practice and relevant legislation
• Identify, screen and recruit eligible participants into research studies
• Support participant retention and follow up throughout the duration of studies
• Obtain informed consent from research participants where appropriately delegated and trained
• Conduct study visits and research assessments in accordance with study requirements
• Perform clinical procedures including venepuncture, observations and specimen collection as required by study protocols
• Administer investigational medicinal products and study interventions where appropriately delegated and trained
• Monitor participant safety and promptly escalate concerns to the principal investigator or appropriate clinician
• Ensure participants receive high quality, safe and patient centred care throughout their involvement in research
• Maintain accurate and timely study documentation
• Complete electronic and paper based case report forms and data entry systems
• Maintain investigator site files and essential study documentation
• Ensure research records are maintained in accordance with regulatory and sponsor requirements
• Assist with study set up activities including feasibility assessments, site initiation visits and study close down procedures
• Support monitoring visits, audits and inspections
• Assist in the preparation and maintenance of delegation logs, screening logs and recruitment trackers
• Collect, process, package and ship biological samples in accordance with study protocols and laboratory requirements
• Ensure samples are handled and stored safely and appropriately
• Maintain accurate records relating to sample collection and shipment
• Work in accordance with good clinical practice and all applicable research regulations
• Maintain confidentiality and comply with information governance requirements
• Report protocol deviations, adverse events and serious adverse events in accordance with study requirements
• Participate in quality improvement activities to enhance research delivery
• Contribute to the development and review of local research procedures and processes
• Develop effective working relationships with participants, investigators, sponsors, research networks and partner organisations
• Act as a professional representative of Ashton Medical Group and the NIHR Greater Manchester Commercial Research Delivery Centre Primary Care
• Work collaboratively with multidisciplinary teams to ensure successful study delivery
• Support the promotion of research opportunities within primary care and local communities
• Contribute to initiatives aimed at improving participation from underserved and underrepresented populations
• Maintain nursing registration and professional competence
• Participate in mandatory training and continuing professional development
• Undertake and maintain good clinical practice training
• Keep up to date with developments in clinical research and research governance
• Participate in appraisal and personal development planning processes
• Work flexibly to meet the needs of the service
• Support the wider research team as required
• Undertake any other duties commensurate with the responsibilities of the post
• Occasionally travel to partner sites across Greater Manchester to support research delivery

This job description is intended as a guide to the principal duties and responsibilities of the role and may be amended following consultation to meet the changing needs of the service.

Person Specification
Qualifications
Essential

• Registered Nurse with current Nursing and Midwifery Council registration
• Degree level qualification in Nursing or equivalent professional qualification
• Evidence of continuing professional development
• Excellent communication and interpersonal skills
• Ability to communicate complex information clearly and effectively to patients and colleagues
• Strong organisational and time management skills
• Ability to prioritise workload and work to deadlines
• Ability to work independently and as part of a multidisciplinary team
• Good written and verbal communication skills
• Competent in the use of information technology and electronic record systems
• Understanding of patient confidentiality and information governance requirements
• Ability to maintain accurate clinical and research records
• Commitment to delivering high quality patient centred care
• Willingness to undertake Good Clinical Practice training and other research related training
• Ability to travel occasionally across Greater Manchester to support research delivery
• Flexible approach to working and service requirements

Desirable

• Previous experience working in clinical research
• Good Clinical Practice certification
• Experience of participant recruitment and informed consent
• Experience of delivering clinical trials within primary care, community or secondary care settings
• Venepuncture competency
• Experience of collecting, processing and shipping biological samples
• Knowledge of clinical research regulations and governance requirements
• Experience of maintaining study documentation and research records
• Experience of electronic data capture systems
• Experience of working with commercial clinical trials
• Experience of working with diverse and underserved populations
• Knowledge of the National Institute for Health and Care Research research infrastructure

Experience
Essential

• Experience working as a registered nurse in a clinical setting
• Experience of delivering high quality patient centred care
• Experience of working within multidisciplinary teams
• Experience of maintaining accurate clinical records and documentation
• Experience of communicating effectively with patients, carers and healthcare professionals
• Experience of managing competing priorities and working independently when required

Desirable

• Experience working within clinical research
• Experience recruiting participants into research studies or service improvement projects
• Experience obtaining informed consent
• Experience conducting study visits or clinical assessments
• Experience of venepuncture and specimen collection
• Experience of processing and handling biological samples
• Experience of maintaining research documentation and investigator site files
• Experience using electronic data capture systems
• Experience working on commercial clinical trials
• Experience working within primary care research settings
• Experience supporting monitoring visits, audits or inspections
• Experience working with underserved or underrepresented populations

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.
Applicants must have current UK professional registration.