Clinical Research Associate (ONCOLOGY)
About the department
The Oncology team has worked on over 500 studies. We are working on several high profile molecular target cancer therapies, traditional chemotherapy as well as those involving targeted therapies with small molecules, immunotherapy and vaccine, virus and gene therapies. The Oncology Clinical Operations team is a smaller business unit so you have genuine opportunities to grow and take on more responsibility whilst knowing you are part of strategically placed Global CRO. Team member expertise is matched to projects where possible and we offer a positive and friendly working environment. Strong team spirit where staff are all pulling together as a cohesive unit with a genuine contribution to global Oncology research.
Job Primary Functions
Prepare and conduct site visits including (but not limited to): qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs, local requirements, the protocol and project plans as well as providing timely and comprehensive visit and status (i.e. patient recruitment) reports.
Communicate effectively with Chiltern Project Team members (i.e. Clinical Team Leader, Project Managers, Safety and Data Management) to ensure study completion per company and client requirements and timelines. Being a pro-active member in team calls and act as a role model. May support in the creation of CRA working tools based on the experience on the project.
Proactively communicate with study sites and follow-up on all open issues in order to meet the project timelines. Ensure that all study-related documentation is tracked, printed, and filed as required by Chiltern SOPs, regulatory requirements, and other protocols.
To ensure that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files.
May support in mentoring less experienced CRAs on project or department tasks and requirements.
May support in conducting quality control accompanied visits with CRAs level 1 or 2.
Perform other duties as required by the Department or Project Team.
WE WELCOME APPLICATIONS FROM THE WIDER EU!
Full time permanent position in the UK
Applicants must be able to work full time in the UK without restrictions
UK accredited Life Sciences degree or nursing qualification is essential
Previous experience of monitoring multiple sites for commercial Oncology studies is a must (Please make your experience clear in your application)
Significant work experience within the CRA job function
Understanding of the principles of ICH GCP and regulatory requirements
Good oral and written communication, organisational skills and personal presentation
The ability to communicate effectively in English
Experience working within a team environment under time and resource pressures
Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices
Confident dealing with external and internal clients and providers
Please note this is a permanent role and we cannot consider agency submissions or freelancers for these roles
Please send your CV and cover letter to email@example.com or call Marc on 01753 216664 for further information OR go ahead and apply on pharmiweb.
key words oncology, clinical research associate, CRA, senior clinical site monitor, site monitoring, cancer, site management, senior CRA