Clinical Trial Coordinator

7 months ago

Headington, United Kingdom Oxford University Hospitals NHS Foundation Trust Full time

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.

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 will be delighted to answer any questions you may have regarding this exciting opportunity.

The Trust comprises of four hospitals - theJohn Radcliffe Hospital,Churchill HospitalandNuffield Orthopaedic Centrein Headington and theHorton General Hospitalin Banbury.

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 centre’s 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.
- 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
- 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 fol

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