Directorate Research Coordinator

Job description

Job responsibilities

JOB DETAILS

Job Title: Research & Innovation Coordinator: Directorate based

Grade: AfC7

Responsible to: Neuroscience Deputy Operations Director Reports to: CRIO Research & Innovation Manager

Location: Royal Hallamshire Hospital

Minimum Requirements:

• Educated to masters degree level or clinical equivalent with health-related research experience in an NHS, university or commercial research setting

JOB PURPOSE

To promote the profile of clinical research and innovation in the Directorate of Neurosciences through:

• academic support
• governance support
• quality assurance
• servicing the Directorate Research & Innovation Executive
• fulfilling reporting requirements
• assisting with the sourcing of research & innovation funding and grants
• maintaining the directorate research & innovation website

MAIN DUTIES AND RESPONSIBILITIES

AUTHORISATION AND MONITORING OF STUDIES Directorate Research & Innovation Co-ordinators will provide advice and support to investigators in their designated Trust directorates and act as their main point of contact, including:

Pre-Award/Submissions

Grant studies:

• keep staff informed of research and innovation opportunities from funders;
• keep staff informed of research and innovation opportunities via specialty / priority groups
• perform study feasibility assessments in conjunction with the Directorate Research and Innovation Executive(s), ensuring congruence with directorate strategy, clinical feasibility, ethical issues, satisfactory facilities and personnel to perform research and innovation projects;
• register studies with the Clinical Research and Innovation Office;
• identify costs in study protocols and agree charges together with Research Accountant, in line with local and NIHR requirements

Industry studies:

• engage with the Clinical Research and Innovation Office industry team to alert researchers to pharma opportunities;
• register studies with the Clinical Research and Innovation Office;
• perform study feasibility assessments in conjunction with the Directorate Research Executive, ensuring congruence with directorate strategy, clinical feasibility, ethical issues, satisfactory facilities and personnel to perform research projects;
• identify costs in study protocols and agree charges together with Research Accountant in line with local and NIHR requirements;
• assist investigators with submissions.

Governance

The Directorate Research & Innovation Co-ordinator will provide investigators with a full support service and guidance at all stages of the research and innovation submission process using expert knowledge in accordance with Clinical Research and Innovation Office procedures, HRA, and international regulatory frameworks including EU Medicines for Human Use (Clinical Trials) Regulations 2004 and amendments, Good Clinical Practice, UK Policy Framework for Health and Social Care Research 2017 and amendments, Medical Devices Regulations, UK law (Human Tissue Act, Data Protection Act and Mental Capacity Act).

• advise and assist investigators with submissions for Research & Innovation Governance Confirmation of Capacity and Capability, completing and co-ordinating the submission;
• track all applications through the submission process to ensure approvals are received in a timely manner, communicating the process with investigators, senior members of the research and innovation team, research sponsors, the Clinical Research and Innovation Office, Clinical Research Facilities of the Trust, and Sheffield Universities;
• set up project specific site files;
• advise and assist investigators with submissions to HRA and completing and collating all necessary documentation prior to submission, supporting investigators in completion of the IRAS form enabling them to submit to HRA and REC prior to commencement and ensuring updates and amendments are reported in a timely fashion;
• support researchers and liaise with the Clinical Research and Innovation Office to complete and submit Clinical Trial Authorisation Applications to EU Regulatory Authorities including EMEA and MHRA, advise and assist investigators to complete the necessary documentation required by the research sponsor when making regulatory applications for Clinical Trial Authorisation for studies involving Investigational Medicinal Products and/or Medical Devices;
• assist in co-ordinating the completion and signatures of the local approvals form, liaising with Pharmacy, Imaging, Laboratory Medicine Information Governance and any other study specific departments, as necessary

Research & Innovation FacilitationAttend study start up, progress and close-down meetings as required. Ensure the Investigator team maintains an up to date Investigator Site File.

• liaise with and provide support between study centres (if originating outside the Trust) and liaise with outside centres for studies originating in Sheffield where the Trust is the lead site
• support the Clinical Research and Innovation Office to perform pharmacovigilance requirements for Trust sponsored drug studies;
• ensure the Investigator team maintains an up to date Investigator Site File;
• participate in the regular follow-up with investigators on project progress, tracking against target in conjunction with Directorate Executive;
• maintain directorates entries on the CRIO research & innovation database to ensure accuracy of data

Monitoring, Audits & InspectionsAs and when required be an active member of the audit team for Clinical Research and Innovation Office monitoring and Regulatory Authority inspection, undertaking audits, analysing findings and contributing to final report for designated directorates;

• report alleged research misconduct to the Clinical Research and Innovation Office and the Directorate Research Executive;
• review and report findings on investigator site files to the Clinical Research and Innovation Office and Directorate Research & Innovation Executive;
• liaise with research team, including Chief Investigator, Principal Investigator, Research Nurses, Sponsor and Clinical Research and Innovation Office as appropriate for monitoring visits;
• prepare and facilitate external Monitoring, Audit and Inspections in conjunction with the Clinical Research and Innovation Office.

Reporting Requirements

• maintain and review Directorates sections of Clinical Research and Innovation Office database for recording and reporting all Directorate activity;
• develop and maintain links for reporting accrual data for YHCRN portfolio studies;
• develop and maintain performance monitoring of recruitment to studies in the Directorate;
• contribute to routine data reporting systems including Pharmacovigilance, AE and SAE reports;
• provide regular up to date reports on Directorate activity for the Directorate Executive, Clinical Research and Innovation Office, YHCRN, NIHR and DHSC.

Person Specification

Qualifications

Essential

• Educated to masters level in health-related/biomedical sciences or Registered Nurse/AHP qualification and research qualification or equivalent experience

Desirable

• PhD
• Post-graduate certificate in Clinical Research
• Teaching qualification

Experience

Essential

• Experience of clinical or biomedical research in an NHS, academic or commercial environment
• Experience of co-ordinating pharmaceutical research or grant funded research

Desirable

• Experience of clinical research audit, monitoring and inspection
• Experience in a variety of clinical settings

Further Training

Essential

• Knowledge of the research process and research methods applicable to health settings
• Knowledge of Department of Health/NIHR research strategy
• Knowledge of research legislation including research governance, ICH GCP and Medicines for Human Use Regulations
• Knowledge of governance arrangements for ethics
• Proven project and organisational skills
• Experience of tutoring and teaching
• IT skills

Desirable

• Experience of designing teaching materials

Special Skills/Aptitude

Essential

• Ability to interpret complex documents including European and national legislation, Department of Health policies and Acts of Parliament
• Highly motivated
• Highly organised
• Ability to work independently
• Demonstrable attention to detail
• Excellent written communication skills
• Excellent interpersonal skills
• Proven ability to develop effective working relationships with staff at all levels
• Proactive in fulfilling needs of researchers

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).

Employer details

Employer name

Sheffield Teaching Hospitals NHS Foundation Trust

Address

Royal Hallamshire Hospital

Glossop Road

Sheffield

S10 2JF

Employer's website

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