Clinical Research Associate II in Hertfordshire
Brandon Whates is recruiting for a Clinical Research Associate II to join a a well known global CRO who work across both pharma & biotech industries, working field based UK wide on a permanent basis.
The main purpose of the role will be:
- To perform assigned tasks within clinical research studies and projects in accordance with company procedures, global, local and specific regulations, as defined by the Project Manager.
- Tasks include, but are not limited to, assistance with regulatory and ethics applications, study document development and management, investigational site management, study materials management, site logistics coordination, training and report preparation.
- Manage assigned clinical projects to the Client's defined objectives, timelines and budget.
- Prepare project-specific support materials and template in accordance to protocol and other specifications and/or manage their production.
- Perform site identification, site feasibility and site selection as required.
- Manage assigned investigational sites from pre-study to close-out and archiving, in accordance with company procedures, global, local and other specified regulations.
- Conduct technical and protocol training of site personnel, as required.
- Manage the content of project Trial Master Files and ensure its accuracy and completeness.
- Ensure timely, effective communication within site teams, with the Company and as appropriate, with Client.
- Prepare and manage regulatory and ethics applications for clinical research studies.
- Provide regular progress updates to the project manager if applicable.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Science Graduate, or appropriate level of experience as a health care professional.
- Previous monitoring experience in the pharmaceutical industry.
- Basic project management skills; demonstrates competence in coordinating appropriately delegated tasks to pre-defined requirements, including planning, timelines, tracking and reporting.
- Knowledge of software systems (EDC, CTMS, eTMF).
- Able to coach, mentor site personnel and less experienced or new CRA.
- Driving license and a willingness to travel.
For more information or to apply for this position, please contact Brandon Whates on 01438 768715 or by email on firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44304 in all correspondence.