Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,300 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.
- Chiltern is looking to recruit an experienced monitor based in Lisbon to work in the role of Clinical Research Associate (CRA) for our Oncology Department.
- Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.
- Assist with document submissions to local authorities
- To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required
- Ensure that all study related communication including e-mail is tracked, printed and filed as required
- To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA
- To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study
- To assemble files and ensure documents for the trial master file accurately reflect the progress of the study
- Other Ad-Hoc CRA duties
- A BSc or BA degree in a biomedical or related life science, or nursing qualification
- Previous CRA experience within clinical research of approximately 2 years
- Previous experience within Oncology is mandatory
- Good clinical knowledge with an understanding of medical terminology
- An understanding of the basics of physiology and pharmacology
- Understanding of the principles of ICH GCP and regulatory requirements
- Experience using a clinical trial management system
- Preferable experience using a clinical trial management system (CPMS)
- Experience as a CRA on single site and/or multicentre trials
- Good oral and written communication, organizational skills and personal presentation
- The ability to communicate effectively in English
- Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
- Permanent full time position
- Office based or Home based in Lisbon