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1. Planning and organisation
a. To be responsible for the monitoring, conduct, progress review and documentation of Trust sponsored clinical trials by reviewing sponsor and site trial documents and performing source document verification (SDV) in accordance with ICH GCP guidelines.
b. Initiate and oversee monitoring plans for Trust sponsored clinical trials
c. Ensure that the monitoring plans for multi-site clinical trials are reviewed and approved prior to trial initiation.
d. To ensure that all appropriate medication manufacture, supply and release documentation is in place before the trial commences.
e. To ensure all trial related Standard Operational Procedures (SOPs) are adhered to and in particular the recording, reporting and tracking of Serious Adverse Events and Adverse Reactions.
f. To coordinate trial initiation visits before any research activity commences, to include review of facilities where trial activity is taking place and obtaining a signed Investigator agreement highlighting research responsibilities.
g. To ensure each trial has a system for documenting IMP drug accountability and traceability.
h. To ensure end of trial reporting and publishing of results is conducted according to regulation.
2. Analytical
a. Assist the Trust in preparation for external audits and inspections to ensure the Trust meets its legal requirements for trial sponsorship.
b. Review trial protocols using risk assessment tools and compile individual monitoring plans commensurate with the scale of the trial for sign-off by the Clinical Trial Project Manager.
c. To review, in conjunction with the trial Chief Investigator any monitoring reports obtained from non-CWFT sites and ensure compliance requirements are being maintained.
d. Assess trial activity against current regulation to support up-to-date research practice.
3. Communication
a. The post holder will need to provide complex advice to investigators, trial managers and research staff on the monitoring, conduct, progress, review and documentation of clinical trials.
b. Arrange meetings with research teams to monitor clinical trial activity and resolve data queries.
c. To act as a primary contact for external sites participating in Trust sponsored trials, supporting trial set up, management, data monitoring and consolidation and close-out visits.
d. To provide written reports on monitoring findings and progress to the trial Chief Investigators, research teams and the CWFT Project Managers.
e. Escalate any key monitoring findings to the CWFT Project Managers for review and action.
f. To assist in the further development of the Research Department and interact with a wide range of stakeholders within and outside the Trust.
4. Information resources
a. To maintain a report of monitoring findings to be used in trial audit and for updating CWFT research training.
b. Write reports and follow up letters to sites following site visits and monitor and record follow up of action points resulting from those visits
c. Utilise electronic data capture systems for monitoring activity, as applicable.
d. Provide training to Trust staff at all levels on CWFT SOPs and compliance requirements, and support workshop sessions relating to trial monitoring and data management.
5. Research and Development
a. To assist the CWFT Project Management teams, Research Operations Manager in collating data on CWFT clinical trial activity.
b. Coordinate trial monitoring activity with researchers and other applicable departments of the Trust.
c. Review monitoring practice and recommend any changes or developments to the CWFT Project Management team.
6. Other duties
a. Provide cover for colleagues as appropriate.
b. Assist in producing ad hoc reports and in project work.
c. Undertake any other duties requested as appropriate to the job level.
d. Support the Research Departments audit program by conducting and following up audits allocated by the Research Clinical Studies Officer.
The Clinical Trials Monitor post is based in the Research & Development Department with a focus to lead on the monitoring of clinical trials sponsored by Chelsea and Westminster Hospital NHS Foundation Trust (CWFT).
The post holder will report directly to the Regulatory Compliance Manager and work with them for studyset up, routine monitoring and the close out of both clinical trials of investigational medicinal products (CTIMPs) and non-CTIMPS on behalf of CWFT.
The Post holder will support the CWFT Sponsor Team and Chief Investigators by monitoring studies in accordance with the monitoring plan, protocol, regulatory requirements, SOP's and GCP. Conducting on-site, remote and central monitoring visits as outlined in the monitoring plans and writing reports, tracking non-compliances, and escalating findings following the visits. The post holder will be the main point of contact for sites hosting CWFT studies and will also support the CWFT Sponsor Team in improving sponsorship processes and monitoring strategy.
To be responsible for the monitoring, conduct, progress review and documentation of Trust sponsored clinical trials by reviewing sponsor and site trial documents and performing source document verification (SDV) in accordance with ICH GCP guidelines.
To act as a primary contact for external sites participating in Trust sponsored trials, supporting trial set up, management, data monitoring and consolidation and close-out visits.
1. Planning and organisation
a. To be responsible for the monitoring, conduct, progress review and documentation of Trust sponsored clinical trials by reviewing sponsor and site trial documents and performing source document verification (SDV) in accordance with ICH GCP guidelines.
b. Initiate and oversee monitoring plans for Trust sponsored clinical trials
c. Ensure that the monitoring plans for multi-site clinical trials are reviewed and approved prior to trial initiation.
d. To ensure that all appropriate medication manufacture, supply and release documentation is in place before the trial commences.
e. To ensure all trial related Standard Operational Procedures (SOPs) are adhered to and in particular the recording, reporting and tracking of Serious Adverse Events and Adverse Reactions.
f. To coordinate trial initiation visits before any research activity commences, to include review of facilities where trial activity is taking place and obtaining a signed Investigator agreement highlighting research responsibilities.
g. To ensure each trial has a system for documenting IMP drug accountability and traceability.
h. To ensure end of trial reporting and publishing of results is conducted according to regulation.
2. Analytical
a. Assist the Trust in preparation for external audits and inspections to ensure the Trust meets its legal requirements for trial sponsorship.
b. Review trial protocols using risk assessment tools and compile individual monitoring plans commensurate with the scale of the trial for sign-off by the Clinical Trial Project Manager.
c. To review, in conjunction with the trial Chief Investigator any monitoring reports obtained from non-CWFT sites and ensure compliance requirements are being maintained.
d. Assess trial activity against current regulation to support up-to-date research practice.
3. Communication
a. The post holder will need to provide complex advice to investigators, trial managers and research staff on the monitoring, conduct, progress, review and documentation of clinical trials.
b. Arrange meetings with research teams to monitor clinical trial activity and resolve data queries.
c. To act as a primary contact for external sites participating in Trust sponsored trials, supporting trial set up, management, data monitoring and consolidation and close-out visits.
d. To provide written reports on monitoring findings and progress to the trial Chief Investigators, research teams and the CWFT Project Managers.
e. Escalate any key monitoring findings to the CWFT Project Managers for review and action.
f. To assist in the further development of the Research Department and interact with a wide range of stakeholders within and outside the Trust.
4. Information resources
a. To maintain a report of monitoring findings to be used in trial audit and for updating CWFT research training.
b. Write reports and follow up letters to sites following site visits and monitor and record follow up of action points resulting from those visits
c. Utilise electronic data capture systems for monitoring activity, as applicable.
d. Provide training to Trust staff at all levels on CWFT SOPs and compliance requirements, and support workshop sessions relating to trial monitoring and data management.
5. Research and Development
a. To assist the CWFT Project Management teams, Research Operations Manager in collating data on CWFT clinical trial activity.
b. Coordinate trial monitoring activity with researchers and other applicable departments of the Trust.
c. Review monitoring practice and recommend any changes or developments to the CWFT Project Management team.
6. Other duties
a. Provide cover for colleagues as appropriate.
b. Assist in producing ad hoc reports and in project work.
c. Undertake any other duties requested as appropriate to the job level.
d. Support the Research Departments audit program by conducting and following up audits allocated by the Research Clinical Studies Officer.
The Clinical Trials Monitor post is based in the Research & Development Department with a focus to lead on the monitoring of clinical trials sponsored by Chelsea and Westminster Hospital NHS Foundation Trust (CWFT).
The post holder will report directly to the Regulatory Compliance Manager and work with them for studyset up, routine monitoring and the close out of both clinical trials of investigational medicinal products (CTIMPs) and non-CTIMPS on behalf of CWFT.
The Post holder will support the CWFT Sponsor Team and Chief Investigators by monitoring studies in accordance with the monitoring plan, protocol, regulatory requirements, SOP's and GCP. Conducting on-site, remote and central monitoring visits as outlined in the monitoring plans and writing reports, tracking non-compliances, and escalating findings following the visits. The post holder will be the main point of contact for sites hosting CWFT studies and will also support the CWFT Sponsor Team in improving sponsorship processes and monitoring strategy.
To be responsible for the monitoring, conduct, progress review and documentation of Trust sponsored clinical trials by reviewing sponsor and site trial documents and performing source document verification (SDV) in accordance with ICH GCP guidelines.
To act as a primary contact for external sites participating in Trust sponsored trials, supporting trial set up, management, data monitoring and consolidation and close-out visits.
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