Clinical Trial Coordinator
Contract length: 4-5 months
Location: Central London
Rate: £35k - £37k per annum, pro rata (hosted)
Start date: ASAP
Interview process: 1 stage interview via Microsoft teams
A new opportunity to work for an academic institution within clinical research has come to light. In this Clinical Trial Coordinator position, you will assist in facilitating the set-up and running of several studies. You will be ensuring optimal data collection and participation in a monitoring program are run to ICH-GCP. You will also assist the Project Lead in developing and maintaining the CECM trials portfolio. The ideal candidate will be proactive, have effective written and verbal communication, and demonstrate a critical and intelligent attention to detail.
Responsibilities:
• Maintaining and updating trial documentation, including trial specific procedures and case report forms (CRF).
• Ensuring sites have all essential documents
• Ensuring all current regulatory requirements are met and approvals are obtained.
• Producing reports as required by the funder, Sponsor, ethics committee and regulatory authorities.
• Ensuring biological samples are sent to central laboratories
• Preparing protocol amendments for approval, as required, and disseminating them to sites.
• Data collection and entry
• Ensuring adherence to the protocol and responding to queries about the trial.
• Ensuring prompt reporting of suspected unexpected serious adverse reactions and serious adverse events from sites and obtaining all relevant information.
• Producing regular trial updates/newsletters etc. to sites.
• Preparing and maintaining a trial risk assessment and monitoring plan
• Liaising with site staff to resolve queries raised during monitoring visits.
Requirements:
· Graduate in biological science or allied health field
· Understanding of GCP
· Knowledge of local and national clinical trial regulations
· Previous experience in clinical trial research
· Experience of existing UK clinical research structures, regulatory and ethical systems
· Some experience of developing and maintaining clinical trial documentation (i.e. protocol, patient information sheets and case report forms)
· Some experience of the Integrated Research Application System (IRAS) / CWOW
· Demonstrable IT skills
If you would like more information on this role or think you would be a good fit, please contact [email protected]