Contract Clinical Research Associate - Czech Republic

This role will see you with direct responsibility for all site activities for the in-country aspects of these exciting Phase III studies.

You will have involvement with all aspects of the site selection, set-up and initiation, patient recruitment and on-going monitoring activities across a network of sites throughout Europe. This is a role very different from the normal CRA-type role and is genuinely one of a kind.

If you have a strong oncology monitoring background, please get in touch as soon as possible.

Responsibilities:

• Responsible for the successful start-up, monitoring and execution of studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at responsible sites
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• May be involved, when needed, in other areas of study management and staff training

Requirements:

• Life science degree (or equivalent)
• Minimum 3 years of independent site monitoring experience
• Previous experience within oncology studies
• Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall global drug development
• Thorough understanding of FDA, EMA, ICH and GCP guidelines and applicable local regulations
• Ability to travel up to 50-65%

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.

To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.

Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.