Clinical Project Associate
- Experience Level
- Experienced (non-manager)
Hobson Prior has partnered with a healthcare technology organisation who are focused on developing drug + digital combination products. Our client is looking for a Clinical Project Associate to work with Project/Clinical Leads on activities supporting the conduct of designated clinical projects and tasks. This role is based in London with the flexibility to be remote based.
Please note that to be considered for this role you must have the right to work in this location.
- Support set-up conduct and reporting of clinical studies e.g. feasibility work, essential document finalization, participant enrolment, progress tracking, data management, analysis and read-out.
- Support the creation and finalization of essential clinical documents including study protocols, study reports, clinical evaluation plans and reports, and applicable components of clinical trial and marketing authorization applications to applicable regulatory authorities.
- Track project status e.g. enrolled and completed participant numbers in clinical studies, collect and maintain tracking data and provide updates on a regular and as required basis.
- Provide technical support for clinical project utilization of the organisation's mobile phone applications in collaboration with the organisation's software engineers.
- Support towards drafting and issuing legal and controlled documents e.g. CDAs, MSAs, Work Orders, DPAs, Consultancy Agreements.
- Support the identification, selection and management of service providers to undertake clinical project work on behalf of the organisation.
- Assistance in oversight of service providers, investigational sites and third parties essential to the conduct of the organisation clinical projects.
- Support the resolution of issues arising during the course of the clinical projects.
- Support presentations on project progress when required (to internal and/or external audiences). Create and maintain structured electronic and paper filing systems relating to essential and other documents associated with clinical projects ensuring that for clinical trials the Study/Sponsor Oversight Files and Trial Master Files are maintained to inspection-ready / required standard(per SOP).
- Tracking, filing and archiving of essential documents.
- Assistance with clinical project budgeting and forecasting, invoice tracking and accruals.
- Any other assigned duties.
- Positive attitude with a solutions-oriented mindset.
- Ability to work in regulated environments requiring compliance with standard operating procedures, controlled document storage and/or regulatory compliance. Knowledge of ICH-GCP guidelines where relevant.
- Good communication skills, ensuring communications are professional.
- Accuracy, with good attention to detail.
- Good organizational and administrative skills and an aptitude for prioritization and forward planning. Proactive and use of initiative with a positive creative attitude.
- Degree in scientific discipline (ideally Life Science).
- Experience in clinical study conduct gained within the pharmaceutical/biotech sector, academic institution or a CRO.
- A basic level knowledge and experience of clinical research, regulatory standards and quality systems in the context of clinical project conduct.
- Experience of financial/contract support.
- Computer literacy including Microsoft Office and other applications.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.