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Clinical Trials Monitor
| Posting date: | 25 March 2025 |
|---|---|
| Salary: | £46,148.00 to £52,809.00 per year |
| Additional salary information: | £46148.00 - £52809.00 a year |
| Hours: | Full time |
| Closing date: | 04 April 2025 |
| Location: | Manchester, M20 4BX |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9413-25-0217 |
Summary
1.0 Clinical Trials Monitoring Works collaboratively with research management teams to develop/oversee and keep updated risk-based monitoring plans for all research studies sponsored and/or managed by The Christie. Conducts continuous monitoring activities (onsite and remote) in accordance with a monitoring plan and applicable regulatory requirement and best practice standards. Using analytical skills and knowledge will implement site management activities to ensure compliance with protocol, GCP, and local processes to secure data integrity and patient safety. Ensure appropriate Corrective Action Preventative Action plans are implemented for issues arising during monitoring visits. Attend the site initiation visit for all clinical trials sponsored and/or managed by the Christie where a CTU has not been engaged. Oversee close-out of clinical trials in accordance with relevant regulations and SOPs. Adhere to SOPs / work instructions to produce written reports on monitoring activities and to develop subsequent action plans for resolution of queries and ensure that they are resolved. Act as a point of contact for queries from research management and delivery teams regarding the ongoing conduct of clinical trials. Maintain regular contact with research management and delivery teams responsible for clinical trials sponsored and/or managed by The Christie by attending the team meetings (where appropriate) to ensure they have up to date information on trial progress including recruitment data. 2.0 Communication and Relationships Build strong relationships and have direct communication with other members of the trial management team to enable smooth running of a clinical trial during its life cycle. Keep the Senior Research Governance Manager and quality manager informed about ongoing monitoring activities and compliance issues identified as part of monitoring visits. Support the pharmacovigilance function in ensuring that adverse events identified through routine monitoring activities are managed in accordance with relevant regulations. Support Trial Management Groups in ensuring that findings from routine monitoring activities are managed in accordance with protocol and relevant regulations. Maintain and develop active communicate channels with relevant stakeholders. Actively contribute to maintaining and building a high performing quality function that ensures the highest standards of research governance are maintained. 3.0 Education and Training Keep abreast of new developments and/or requirements for clinical trials monitoring and disseminate changes to clinical research delivery and management teams by way of presentations and/or group meetings. With the Research Integrity and Governance Manager, lead the design and delivery of all training pertinent to clinical trials monitoring necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio, this includes leading development of specific training according to demand. Work with investigator sites to ensure research delivery teams are trained and re- trained in clinical trial protocols as required. Participates in inspection readiness training Maintain professional development whilst evaluating own specialist knowledge through a process of appraisal and personal development planning to satisfy the requirements relating to the job 4.0 Financial Resources Advise on monitoring requirements to inform clinical trial grants Keep detailed records of expenses and ensure all submissions for payments is completed in a timely manner. Participate in the management of financial resources allocated to own areas ensure monitoring plans are developed in accordance with allocated monitoring budget Be responsible for the safe use of ICT hardware and software. Ensure Trust Standing Financial Instructions are followed 5.0 Information Resources To maintain a database of monitoring findings Utilise electronic data capture systems for monitoring activity, as applicable 6.0 Research and Development To assist the sponsorship team members in collating data on Trust sponsored clinical trial activity. Coordinate trial monitoring activity. Review monitoring practice and make recommendations for change 7.0 Other Duties Review amendments to protocols that are sponsored by The Christie to consider any adaptions required to monitoring plans Contribute to review of Standard Operating Procedures (SOPs), policies and processes pertinent to clinical trials monitoring, and take responsibility for proposing necessary changes or additions to ensure legal and regulatory compliance and contribute to process improvement Participate in relevant meetings including study specific, role specific and wider team meetings as required with responsibility for taking and distributing minutes if required. Assist in the preparation for audits or statutory inspection by the MHRA or any other body and assist in the implementation of any corrective plans. Develop links with external national bodies and trial related groups to ensure that the views of the institution are represented. Manage own workload, determining relative priorities for action the majority of the time.