Warning
Mae'r hysbyseb swydd hon wedi dod i ben ac mae'r ceisiadau wedi cau.
Clinical Trials Senior Research Co-ordinator
| Dyddiad hysbysebu: | 01 Mai 2025 |
|---|---|
| Cyflog: | £37,338.00 i £44,962.00 bob blwyddyn |
| Gwybodaeth ychwanegol am y cyflog: | £37338.00 - £44962.00 a year |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 15 Mai 2025 |
| Lleoliad: | Birmingham, B31 2AP |
| Cwmni: | NHS Jobs |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: | C9303-25-0022 |
Crynodeb
To act as lead for the allocated research study team for the set up and approval of any pharmaceutical or medical device clinical trials Establish and maintain effective working relationships across the Trust and with external companies, able to communicate with staff/people at all levels. Ensure relevant internal parties as well as funders are advised of new studies and their progress through to active status. Hardworking and understands the value of teamwork. Good attention to detail. Excellent verbal, telephone, and written communication skills Works independently, recognising own strengths but can seek advice when necessary Provide guidance and support for principal investigators, sharing knowledge of best practice and current legislation/guidance. A large degree of working time is spent at a desk using computer for prolonged periods. Other activities include meetings and walking to other areas of the Trust. Some of the time the post holder will go into clinical areas to visit staff. The post holder may sometimes have to meet with staff out of normal office hours. Collate study documentation in relation to regulatory requirements including quality checking information sheets, samples request forms etc. Maintain a strong and current working knowledge of developments regarding clinical research management regulation and governance and NHS structures and services. Check data for errors, liaise with the clinical team for missing data and ensure full documentation of any queries raised. Ensure costings for all new studies are undertaken, liaising across departments withing ROH to accurately complete the NIHR costing template. To be a member of the west Midlands CRN. To be GCP trained and keep up to date in clinical research. To support with carrying out risk assessments for research studies and assist with implementing mitigating actions or escalating as required. Identify, report and support resolutions of problematic studies and where deviations from agreed timelines are likely. Oversee monitoring of IG incidents, proposing corrective and preventative actions and co-ordinate and assist in culminating an incident investigation report. To proactively ensure the provision of a comprehensive, high quality and efficient administrative service, including identifying improvements to team and/or department working practices. Liaise with finance and research delivery teams to ensure the budgets for inclusion in contracts are appropriate and cover costs of work carried out. Use of research IT systems including the NIHR EDGE online database, IRAS (Integrated Research Application System) and CPMS (Central Portfolio Management System), Portfolio Maps (Research study scoping database), CROSS, REDCap and all Microsoft Office packages. This job description may be reviewed from time to time considering developments and may be amended in consultation with the post holder. Concentration will be required, and the work pattern may be unpredictable and subject to interruptions when updating plans, research reports and meeting short deadlines. The role will act as the main point of contact for support and guidance in relation to the studies portfolio from participating sponsors, funders, pharmaceutical partners, regulatory authorities and the trial oversees committees. Ensuring that appropriate documentation is available for conducting clinical trials alongside the clinical trials protocol and determine which approvals are needed for studies and submissions to HRA, REC, MHRA and other regulatory bodies. The post holder will ensure that research coordinators are compliant with ICH GCP guidelines.