Clinical Research Associate (CRA II)

Clinical Research Associate (CRA II)

ICON

Bulgaria

We are currently recruiting for an experienced Clinical Research Associates 2 in Bulgaria to work on diabetes, obesity, and rare blood and endocrinology studies.

This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

What you will be doing:

The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

• Primary point of contact between site staff and the sponsor;
• Acts as ambassador for the company and contributes to making the sponsor the preferred partner;
• Performing on-site monitoring visits according to plan, document actions and follow up on action plans;
• Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies;
• Train and guide site staff in the protocol and trial procedures to minimise protocol deviations (PDs);
• Train site staff in safety information handling and systems;
• Identify potential risks and proactively take action to prevent or mitigate;
• Collaborate with Data Management/logistics in resolving queries;
• Collection and management of essential documents;
• Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF);
• Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable.

Requirements:

• Bachelor or master degree in Life Sciences or equivalent;
• Minimum of 1.5-3 years previous experience as a CRA n independent on-site monitoring of clinical trials;
• Ability to work occasionally from the sponsor's office;
• Ability to build and maintain relationships with sites;
• High focus on delivery and quality;
• Excellent communication and negotiation skills;
• English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monit.

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