Address
Form of work
SalaryWhat you will be doing:
- Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
- Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
- Proactive site management including:
- Building and maintaining solid and professional relationships with site staff
- Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
- Maintaining site audit/inspection readiness
- Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
- Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
- Responding to site queries and escalating issues in accordance with processes and timelines
- Conducting IP accountability and reconciliation
- Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
- Maintenance of site study supplies
O perational Excellence:
- Contribute to sponsor goals
- Promote operational and scientific excellence
- Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.
You are:
- BA/BS/BSc in the sciences or nursing equivalent
- A trained CRA with on-site monitoring experience
- Comprehensive knowledge and understanding of ICH-GCP
- Fluent oral (face to face and telephone) and written English language skills
- Able and willing to travel up to 60% of the time or as per local requirements
- Possession of a full driver’s license
- Able and willing to work from a designated and appropriate home office as per local requirements
- Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
- Competent computer skills including working knowledge of common software packages
- Working knowledge of trial management databases and on-line systems
- Able to attend a 1 week face to face in-house training course as part of on-boarding training
- Able and willing to work on several protocols/therapy areas
- Experience in phase II and phase III trials (preferred)
- Working knowledge of Electronic Data Capture (preferred)
Experience/working knowledge of the oncology disease area (preferred)
- Experience of Centralized/Risk Based/Targeted monitoring (preferred)
- Experience of working within a metric based environment (preferred)
