Clinical Trial Assistant
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Job Type | Permanent Full Time |
Location | City of London |
Area | Central London, UK |
Sector | Clinical Research |
Salary | See Job Description |
Currency | GBP |
Start Date | 01/09/2018 |
Advertiser | remoteapi |
Job Ref | BBBH680_1530296888 |
Job Views | 150 |
- Description
We have an exciting new opportunity for an experienced Clinical Trial Assistant in London.
As a Clinical Trial Assistant you will be responsible for the support of Clinical Trials and projects, ensuring standardisation and consistency of tracking across studies in accordance with trial SOPs
To provide support to Chief Operating Officer, CPM and study team in order to meet project needs
- Is utilised as point of contact for defined tasks during study and supports COO and CPMs with communication as directed
- Investigator site contact details generated, co-ordinated and maintained
- Logistics of investigator and monitor meetings organised including the development of presentation materials under direction of CPM
- Study telephone cover provided
- Active membership of projects meeting: meetings booked, minutes taken and communicated
- Logistics of CRO/vendor meetings organised and minutes taken
- Areas of improvement identified to manage
- Learnings and recommendations from study debriefs and best practice identified and implemented in collaboration with manager and colleagues
- Consistency maintained across studies within projects
To develop, maintain and manage appropriate study documentation in line with guidance including ICH-GCP, SOPs and current best practice
- Development and distribution of newsletters for investigators and monitors
- Study area managed according to clients standards including set up, access rights and maintenance of study related documents
- Development and maintenance of study specific documents and tracking tools under direction of CPM
- Impact of protocol amendments on study specific documents assessed: updates coordinated as appropriate
- Trial Master Files maintained for studies in accordance with SOP requirements under the direction of CPM
- Documentation provided to support the preparation of clinical study reports and publications
- Health Authority/ IRB submissions and approvals tracked
To drive and track the Expression of Interest process according to SOP
- EoI requests received and handled in a timely fashion
- Meetings organised and managed with appropriate stakeholders invited
- EOI spreadsheet updated and process tracked
- All documentation completely correctly
- Issues escalated as appropriate
To ensure high ethical standards are maintained at all times and there is full compliance with all applicable laws, regulations, codes and internal policies and procedures
- Awareness of and compliance to laws and regulations applicable to projects
- Awareness of and compliance to all policies and procedures including Finance, Procurement, IT and Legal
- Demonstrable ownership of comprehensive understanding of regulations and SOPs: Learning gaps identified and actions taken to access required training
- Attendance at all requisite training sessions and completion of all requisite on-line training and compliance programmes within specified time limit
Degree qualified in Life sciences -Right to work and live in Uk
E mail: CV to bryan@
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