Clinical Trial Assistant / Administrator

Job Location	Manchester Science Park
Education	Not Mentioned
Salary	Salary negotiable
Industry	Not Mentioned
Functional Area	Not Mentioned
Job Type	Permanent, full-time

Job Description

Clinical Trial Assistant (CTA)Phagenesis Limited is a Manchester based medical device company at the forefront of neurological rehabilitation medicine and has developed unique products to treat swallowing dysfunction arising from brain injury.You will be a pivotal part of our small clinical research team and will operate under the guidance of the clinical manager in compliance with International and European standards for Good Clinical Practices (GCPs), ISO14155 and relevant Standard Operating Procedures (SOPs) to administer, maintain and co-ordinate the logistical aspects of our clinical trials.The CTA will be involved in most activities in preparation for study set up, conduct and completion and also acts as a pivotal point of contact and support for the clinical trial team.The main responsibilities are:

To provide general administrative support to the Clinical Operations Department and Clinical Operations team in completion of all required tasks to meet departmental and project goals, including clinical study-specific administrative support

To be familiar with ICH GCP, appropriate regulations, relevant Phagenesis SOPs and internal tracking systems.

To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.

To assist with the coordination of team member tracking.

To assist project teams with study-specific documentation and guidelines as appropriate, flag inconsistencies to manager.

To set up, organize and maintain clinical study documentation (e.g. Trial Master Files, Investigator Site Files, etc.) including preparation for internal/external audits, final reconciliation and archival.

To assist in quality control audits of clinical study documentation (e.g. Trial Master Files, Investigator Site Files, Monitoring Files, etc.).

To co-ordinate ordering/dispatch and tracking of study related materials (e.g. study devices, study files, etc.) as appropriate.

To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.

To copy and route incoming correspondence, internal documentation, etc., as appropriate.

To assist in co-ordination of Investigator payments, if applicable.

To contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).

To assist in the processing and follow-up of safety reports in accordance with Phagenesis SOPs and applicable regulations.

To co-ordinate document translation, if required.

To arrange, attend and occasionally conduct project team and other meetings; thereafter generate meeting minutes.

To assist the Project Manager and project team with study-related meetings (Investigator Meetings, study/team training etc.) coordination, activities preparation, travel arrangements and meeting minutes generation.

To assist in the production of presentation slide decks and other materials, databases and reporting tools etc., as needed for project, departmental and/or business development requirements.

To assist the project team with the submission of documents to regulators, ethic committees and hospitals as required and notify management when expiration of any approvals are approaching,

To generate, check and track departmental and study-specific invoices, obtain necessary approvals for payment where applicable,

Other duties as assigned

The ideal candidate should have the following skills and characteristics:

Minimum 2 years CTA experience within commercial trials,

Life Science Degree,

Excellent organisational skills and attention to detail

Knowledge of ICH GCP and ISO14155

Excellent time management and ability to work to tight deadlines

Self motivated and pro-active

Works well in a team and independently with minimal supervision

IT literate (Excel, Word and database tools)

Previous experience of working in Clinical Research involving Medical Devices,

Knowledge of the Medical Device Industry/Clinical Trial process,

Knowledge of ICH GCP and ISO14155.

We will run rolling review of the applicants until suitable candidates have been invited to interview so early application will increase the likelihood of your application to be considered Required skills

Clinical Research

Clinical Trials

Communication Skills

Accurate Record Keeping

life science degree

Keyskills :
Clinical Research Clinical Trials Communication Skills Accurate Recd Keeping life science degree

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