Job summary
An excellent opportunity has arisen to work with the Oxford Translational Myeloma Centre within Oxford University Hospitals NHS Trust as a Clinical Trial Coordinator on our portfolio of studies. Based within the Churchill Hospital, this is a pivotal role and you will be part of a team taking part in an exciting range of clinical research studies. You will have previous clinical research experience and be educated to degree level or equivalent, you will work within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP. The successful applicant should have a flexible approach to their duties and the ability to work both as part of the team as well as independently. In addition, you will have excellent communication, administrative and IT skills and be supportive and open to new initiatives.
Main duties of the job
Trial Coordinators are responsible for the coordination of specific clinical trials within the centres portfolio. Supervised and line managed by the Trial Manager, they are responsible for ensuring their allocated clinical trials are set up and managed in accordance with regulatory, sponsor and Clinical Research & Development Office (R&D) requirements.
We are seeking a clinical trial coordinator and will consider applicants from a variety of backgrounds and clinical settings who could bring their experiences and skills to our teams. Successful candidates will be interested in clinical research, committed to delivering high standards, and enjoy the challenge of working in a dynamic environment. We are looking for highly motivated individuals with excellent communication, organisational, and time management skills. As a department we are committed to supporting the ongoing development of our staff.
About us
We will be delighted to answer any questions you may have regarding this exciting opportunity.
We look forward to reading your application!
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. Find out more here www.ouh.nhs.uk
The Trust comprises of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.
Job description
Job responsibilities
This post is part of the Oxford Translational Myeloma Centre (OTMC) at Oxford University Hospitals NHS Foundation Trust. The role is responsible for helping the management of the centres portfolio of clinical projects, studies and trials including those sponsored by the Trust.
The key functions of this role are:
To manage and support Clinical Trials Assistants including responsibility for appraisals, professional development and sickness management.
To assist the OTMC Trial Manager in managing the portfolio and workload associated with the coordination of OTMC portfolio studies
Provide advice on all aspects of setting up, conducting and closing out of clinical research
Co-ordinating the design, implementation and management of clinical trials across multiple participating hospital sites, ensuring timely data collection and GCP compliance, and undertaking regular monitoring
Main Tasks and Responsibilities
Management
- Help manage a team of Clinical Trials Assistants including responsibility for appraisals, professional development, sickness management, recruitment, performance management etc.
Clinical Trial Set-Up
- Provide advice for investigators, researchers and their teams and OTMC clinical trials team on all aspects of setting up, conducting and closing out of clinical research projects, studies and trials.
- Assisting with Budget setting and costing of clinical studies, projects and trials.
- Assist investigators in securing external grants and negotiating other forms of external support, in order to ensure trials are adequately resourced.
- Oversee and review protocols, applications to REC, MHRA, R&D and other organizations developed and processed by the clinical trials team, before they are submitted to the Sponsor/R&D.
- Analyse and make definite judgments on particularly complex study designs to determine what applicable current legislation has to be taken into consideration.
- Liaise with PIs, study sponsors, regulatory agencies and government departments, IMP suppliers etc.
Clinical Trials Coordination and conduct of studies
- Ensure the timely and accurate production and submission of all trial related reports (Safety, Progress, Sponsor, Final Study).
- Manage the separate accounts associated with allocated research projects, ensuring trials continue within budget. This will include escalating concerns to the PI where funding issues are identified and providing solutions.
- Oversee the sourcing and ordering of supplies and equipment as required for distribution to participating sites.
- Maintain oversight of Trial Master Files ensuring that the studies are conducted in compliance with all Trust/R&D and OTMC SOPs and conducted to the standards outlined by the relevant British and EU laws, regulations and guidelines. Ensuring remedial action is taken where any discrepancy exists.
- Where required, provide information, advice and support to participants of trials within the department.
Communication & Relationships
- Build strong relationships with Chief Investigators and Principal Investigators to identify their needs from start to completion of a clinical study - from planning stages, grant application, protocol development, submissions for approvals, data collection, data management, statistics, to publication.
- Develop and maintain good relationships with research teams; cultivate an understanding of the role and requirements of the REC, MHRA and R&D departments.
- Prepare and deliver presentations, reports and newsletters to Trust staff, visitors and other stakeholders; and attend meetings as required.
Policy and Service Development
- Contribute to departmental Policies and Procedures where appropriate.
- Develop supporting documentation for researchers including guidance documents and templates for study level documentation where required.
Monitoring and Auditing
- Work closely with the OTMC team to ensure that any issues with coordinated Trust Sponsored CTIMPs are followed up, making a judgment if issues need to be escalated.
- Conduct monitoring visits and/or audits of OTMC portfolio studies and participating sites where required, preparing reports and letters on the outcomes of those activities, escalating issues as they arise. This may include national or international travel dependent on the study.
- Provide assistance during Regulatory Authority Inspections and audits, analysing findings and contributing to the final report where appropriate.
- Prepare and facilitate internal and external auditors, when required.
Planning and Organisation
- Allocate the workload between the clinical trials assistants on an ongoing basis according to new clinical studies, projects or trials received taking account of team workload and other commitments.
- Provide reports to the OTMC Trials Manager on workload, taking into consideration: staffing levels and financial support from research grants.
Job description
Job responsibilities
This post is part of the Oxford Translational Myeloma Centre (OTMC) at Oxford University Hospitals NHS Foundation Trust. The role is responsible for helping the management of the centres portfolio of clinical projects, studies and trials including those sponsored by the Trust.
The key functions of this role are:
To manage and support Clinical Trials Assistants including responsibility for appraisals, professional development and sickness management.
To assist the OTMC Trial Manager in managing the portfolio and workload associated with the coordination of OTMC portfolio studies
Provide advice on all aspects of setting up, conducting and closing out of clinical research
Co-ordinating the design, implementation and management of clinical trials across multiple participating hospital sites, ensuring timely data collection and GCP compliance, and undertaking regular monitoring
Main Tasks and Responsibilities
Management
- Help manage a team of Clinical Trials Assistants including responsibility for appraisals, professional development, sickness management, recruitment, performance management etc.
Clinical Trial Set-Up
- Provide advice for investigators, researchers and their teams and OTMC clinical trials team on all aspects of setting up, conducting and closing out of clinical research projects, studies and trials.
- Assisting with Budget setting and costing of clinical studies, projects and trials.
- Assist investigators in securing external grants and negotiating other forms of external support, in order to ensure trials are adequately resourced.
- Oversee and review protocols, applications to REC, MHRA, R&D and other organizations developed and processed by the clinical trials team, before they are submitted to the Sponsor/R&D.
- Analyse and make definite judgments on particularly complex study designs to determine what applicable current legislation has to be taken into consideration.
- Liaise with PIs, study sponsors, regulatory agencies and government departments, IMP suppliers etc.
Clinical Trials Coordination and conduct of studies
- Ensure the timely and accurate production and submission of all trial related reports (Safety, Progress, Sponsor, Final Study).
- Manage the separate accounts associated with allocated research projects, ensuring trials continue within budget. This will include escalating concerns to the PI where funding issues are identified and providing solutions.
- Oversee the sourcing and ordering of supplies and equipment as required for distribution to participating sites.
- Maintain oversight of Trial Master Files ensuring that the studies are conducted in compliance with all Trust/R&D and OTMC SOPs and conducted to the standards outlined by the relevant British and EU laws, regulations and guidelines. Ensuring remedial action is taken where any discrepancy exists.
- Where required, provide information, advice and support to participants of trials within the department.
Communication & Relationships
- Build strong relationships with Chief Investigators and Principal Investigators to identify their needs from start to completion of a clinical study - from planning stages, grant application, protocol development, submissions for approvals, data collection, data management, statistics, to publication.
- Develop and maintain good relationships with research teams; cultivate an understanding of the role and requirements of the REC, MHRA and R&D departments.
- Prepare and deliver presentations, reports and newsletters to Trust staff, visitors and other stakeholders; and attend meetings as required.
Policy and Service Development
- Contribute to departmental Policies and Procedures where appropriate.
- Develop supporting documentation for researchers including guidance documents and templates for study level documentation where required.
Monitoring and Auditing
- Work closely with the OTMC team to ensure that any issues with coordinated Trust Sponsored CTIMPs are followed up, making a judgment if issues need to be escalated.
- Conduct monitoring visits and/or audits of OTMC portfolio studies and participating sites where required, preparing reports and letters on the outcomes of those activities, escalating issues as they arise. This may include national or international travel dependent on the study.
- Provide assistance during Regulatory Authority Inspections and audits, analysing findings and contributing to the final report where appropriate.
- Prepare and facilitate internal and external auditors, when required.
Planning and Organisation
- Allocate the workload between the clinical trials assistants on an ongoing basis according to new clinical studies, projects or trials received taking account of team workload and other commitments.
- Provide reports to the OTMC Trials Manager on workload, taking into consideration: staffing levels and financial support from research grants.
Person Specification
Separate manual checklist to be used
Essential
- Meets Essential Criteria based on a manual checklist
Desirable
- Meets Desirable Criteria based on a manual checklist
Person Specification
Separate manual checklist to be used
Essential
- Meets Essential Criteria based on a manual checklist
Desirable
- Meets Desirable Criteria based on a manual checklist
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.
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).
Additional information
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.
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).
