Job description

Job responsibilities

Be responsible for the Expression of Interest / Study Selection process for the

relevant specialty.

b. Review and assess trial protocols, consider all potential trials in terms of capacity and

capability and viable recruitment period.

c. Identify and work with the Research Manager to resolve resource implications in

delivering and facilitating clinical research.

d. Assist in the overall setting up, organisation and running of a clinical trial within the

practice to Good Clinical Practice (GCP) guidelines within the Research Governance

framework and adhering to other related regulations/SOPs.

e. To support the recruitment process for new and ongoing clinical trials, assessing patient

suitability and ensuring the correct consent process is followed.

f. To provide advice and guidance to patients with regard to their involvement in clinical

research trials

g. Coordinate logistics for patient visits and perform patient assessments as outlined in

study protocols, including blood collection and centrifugation.

h. Competently interpret clinical records, charts, and care documentation to assess clinical

interventions, medications, and patient responses, ensuring suitability for inclusion in

individual trials

i. Conduct required screening procedures in line with study criteria.

j. To monitor treatment toxicity and/or side effects and to take appropriate action to

reduce the effects of treatment as necessary.

k. To report and record any adverse events and serious adverse events that occur whilst the

patient is being treated on a clinical trial.

l. To work within the NMC Code of Conduct and within your individual scope of professional

conduct.

m. Accurately record all research activity to maintain clear and contemporaneous study

documentation, including the reporting of adverse and serious adverse events.

n. Assist in study close down and the preparation of results of research for presentation as

posters, abstracts, papers or scientific presentations.

o. Work with the Research Manager and research facilitators to ensure accurate costing for

clinical trials and appropriate negotiation of required financial support to deliver clinical

trials.

Person Specification

Other requirements

Essential

• Flexibility to work outside of core office hours
• Disclosure Barring Service (DBS) check
• Occupational Health Clearance

Experience

Essential

• Experience of working as a Research Nurse
• Understanding of research ethics and regulatory framework
• Experience of using EMIS or other alternative Primary Care software
• Experience of working within a research function in primary care
• GP Practice or Primary Care Network

Skills

Essential

• Excellent communication skills (written and oral)
• Strong IT skills
• Clear, polite telephone manner
• Competent in the use of Office and Outlook
• Effective time management (Planning & Organising)
• Ability to work as a team member and autonomously
• Good interpersonal skills
• Ability to follow clinical policy and procedure

Desirable

• EMIS / Systmone / Vision user skills

Personal Qualities

Essential

• Polite and confident
• Flexible and cooperative
• Motivated
• Problem solver with the ability to process information accurately and effectively, interpreting data as required.
• High levels of integrity and loyalty
• Sensitive and empathetic in distressing situations
• Ability to work under pressure / in stressful situations
• Effectively able to communicate and understand the needs of the patient.
• Commitment to ongoing professional development
• Effectively utilises resources
• Punctual and committed to supporting the team effort

Qualifications

Essential

• Registered nurse (NMC)
• Evidence of continuing professional development

Desirable

• Post graduate certificate or diploma in clinical research
• Masters in clinic research or clinical trials.

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.

UK Registration

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

Employer details

Employer name

Ashfields Primary Care Centre

Address

Middlewich Road

Sandbach

Cheshire

CW11 1EQ

United Kingdom

Employer's website

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

Job description

Job responsibilities

This is a management position with primary responsibility for the operational and financial delivery of commercial and non commercial research across two Primary Care settings.

You will:

1. Ensure the delivery and continued growth of a reputable and efficient research function, maintaining the highest standards in line with Good Clinical Practice (GCP) and all regulatory requirements.

2. Responsible for the operational and financial management of the research function on a day to day basis, ensuring that the team delivers its roles and responsibilities for all elements of research governance, quality and assurance.

3. Provide expert research management and governance advice across the partnerships and external teams.

4. Contribute to the strategic direction of the Research Team.

5. Be responsible for ensuring the Expression of Interest / Study Selection process for the relevant specialty is undertaken in an efficient and effective manner.

6. Be responsible for ensuring that the approval of new studies are rapidly achieved and acted upon by the Research Team.

7. Oversee the setting up, organisation and running of a clinical trial within the practices to Good Clinical Practice (GCP) guidelines within the Research Governance framework and adhering to other related regulations/SOPs maintaining effective communication with study sponsors and ensuring standards and KPIs are met at all times escalating to the Principal Investigators as appropriate.

8. Responsible for the establishment and agreement of study contracts with Sponsors and Third Party Contractors for studies as appropriate.

9. Responsible for the necessary infrastructure and training personnel to ensure efficient study set up and management of all studies across both sites.

10. Responsible for the review and management of all systems and processes within the Research team to ensure the team is operating as efficiently and effectively as possible to maximise the study pipeline.

11. Responsible for the financial governance arrangements across both sites ensuring appropriate systems are in place to monitor income and expenditure, identify opportunities for securing potential income via bid opportunities and collaboration.

12. Be responsible for resource implications in delivering and facilitating clinical research, working with the Principal Investigators to identify and resolve.

13. Oversee recruitment processes for new and ongoing clinical trials, ensuring patients are

identified and approached in line with study protocols, eligibility criteria and consent

requirements, recruitment targets are monitored, and risks to recruitment are identified

and mitigated.

14. Ensure the appropriate reporting and recording of any adverse events and serious

adverse events that occur whilst the patient is being treated on a clinical trial.

15. Ensure all research activity is accurately recorded to maintain clear and contemporaneous

study documentation, including adverse event and serious adverse event reporting in line

with study protocols and regulatory requirements.

16. Ensure study close down is undertaken following the appropriate regulations.

17. Ensure that the Research Team actively promotes its research activities through

presentation as posters, abstracts, papers or scientific presentations.

18. Responsible for line management of the Research Team, including setting objectives,

clarifying roles and responsibilities, reviewing workload and supporting effective team

performance.

Secondary Responsibilities

In addition to the primary responsibilities, the Interim Research Manager may be requested to:

a. Participate in practice audit as directed by the audit lead

b. Participate in local initiatives to enhance service delivery and patient care

c. Support and participate in shared learning within the practice

d. To take responsibility for own development and education

e. To participate in annual appraisal process with your line manager

f. Work with staff from other practices to deliver research objectives

g. Undertake all mandatory training and take part in personal development reviews.

19. Liaise with local, regional and national research partners to support integrated research delivery, share learning and develop appropriate joint research initiatives. 20. Compile complex reports to meet internal and external reporting requirements, ensuring information is accurate, timely and appropriate for the intended audience. 21. Represent the Research Team at internal and external meetings and events as required, promote the roles and services of the Research Team, considering improvements and developments at all times. 22. Escalate issues where appropriate particularly around issues of quality, safety and GCP to the Principal Investigators. 23. Lead on performance metrics on behalf of the Principal Investigators. 24. Support the Research Team by ensuring studies are appropriately resourced, staff training requirements are identified and addressed, and workload is reviewed with the Principal Investigators where additional capacity or support is required. 25. Maintain a thorough and up to date knowledge of research policy and landscape through attendance at workshops and meetings and assimilation of information from a range of sources and ensure dissemination of key developments. 26. Collaborate with the Regional Research Delivery Network to identify research opportunities, support study delivery and maintain effective links across the wider research system.

Person Specification

Personal Qualities

Essential

• Polite and confident
• Flexible and cooperative
• Motivated
• Problem solver with the ability to process information accurately
• and effectively, interpreting data as required
• High levels of integrity and loyalty
• Sensitive and empathetic in distressing situations
• Ability to work under pressure / in stressful situations
• Effectively able to communicate and understand the needs of others
• Commitment to ongoing professional development
• Effectively utilises resources
• Punctual and committed to supporting the team effort

Experience

Essential

• Experience of managing multidisciplinary teams
• Experience of financial and contract management
• Experience of successfully developing and implementing new
• systems and processes
• Experience of HR processes, workforce planning and development
• Experience of performance management including appraisals
• Experience of working in a healthcare setting

Desirable

• NHS, primary care or general practice experience, including understanding of how research is delivered within a practice environment.
• Understanding of research ethics and regulatory frameworks
• Experience of using EMIS, SystmOne, Vision or another primary care
• clinical system.

Qualifications

Essential

• Educated to degree level in healthcare, business or a related subject,
• or able to demonstrate equivalent experience.
• Leadership and / or management qualification

Skills

Essential

• Excellent communication skills (written and oral)
• Strong IT skills
• Clear, polite telephone manner
• Competent in the use of Office and Outlook
• Effective time management (Planning & Organising)
• Ability to lead a team, work effectively as a team member and work
• autonomously when required.
• Good interpersonal skills

Desirable

• EMIS / Systmone / Vision user skills

Other requirements

Essential

• Flexibility to work outside of core office hours
• Disclosure Barring Service (DBS) check
• Occupational Health Clearance

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.

Employer details

Employer name

Ashfields Primary Care Centre

Address

Middlewich Road

Sandbach

Cheshire

CW11 1EQ

United Kingdom

Employer's website

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