Hobson Prior are looking for a CRA to join a leading pharmaceutical organisation who are focused on supporting the pharmaceutical and biotechnology industry in the development and commercialisation of products all over the world. This position is on a permanent basis located in Hertfordshire.
- Responsible to prepare project-specific support materials and templates in accordance with protocol and other Specifications.
- Support the preparation of project and monitoring plans; implement activities as described to required quality standards, timelines and any other specifications.
- Complete site identification, site feasibility and site selection as required.
- Manage assigned investigational sites from pre-study to close-out and archiving, including remote or centralized monitoring activities as required.
- Perform on-site monitoring visits from pre-study to close-out.
- Deliver regular progress updates to the Project Lead.
- Conduct technical and protocol training of investigational site personnel, as required.
- Manage the content of project site-level Trial Master Files and ensure accuracy and completeness.
- Ensure timely, effective communication with investigational sites, within project teams, with the organisation and as appropriate, with Client.
- Highly motivated, pro-active approach to tasks; able to work effectively within a team or independently.
- Ability to identify issues proactively.
- Confident presentation skills.
- Competent and confident to work efficiently across company departments and with a variety of external vendors, using various modes of communication (email, letter, telephone).
- Meticulous eye to detail.
- Well-developed language skills.
- Science Graduate, or appropriate level of experience as a health care professional.
- A higher degree is desirable but not essential.
- A minimum of 2 years monitoring experience within the pharmaceutical industry.
- Well-developed knowledge and understanding of the principles of Good Clinical Practice and able to demonstrate practical application.
- Good knowledge of drug development process and clinical study phases and competent level of clinical research literacy and use of terminology.
- Basic project management skills.
- Proficient Microsoft Office user with the ability to create and format documents to a good, consistent standard; efficient use of Internet.
- Previous experience in clinical trial authorisation approval process in local region.
- Previous experience with software systems (EDC, CTMS, eTMF, IXRS).
- Passport with at least 6 months validity.
- Able to travel extensively including overnight stays.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.