Clinical Research Associate II

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

As a Clinical Research Associate II,you will work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.

Hybrid role in Sofia, Bulgaria

Your responsibilities will include:

• Preparation, conduct, and reporting of all types of monitoring visits
• Supporting quality control, such as compliance monitoring and reports review
• Contact for clinical investigators, vendors and support services in regard to study progress
• Delivering training of investigators, site staff and project teams
• Be involved in site identification process and feasibility research
• Support to Regulatory Affairs in procurement of site regulatory documents
• Preparation and delivering of presentations at Investigator’s Meetings
• Maintenance of study-specific automated tracking systems
• Preparation for and attendance at company’s audits; resolution of audit findings

Qualifications

• Degree in Life Sciences (or similar), or an equivalent combination of education, training & experience
• 1 year and a half of independent on-site monitoring experience in Bulgaria, ideally on multiple projects at a time 
• Experience in all types of monitoring visits in Phase II and/or III
• Native Bulgarian and full working proficiency in English
• Experience supporting Oncology studies is beneficial, but not essential
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• As you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel. 

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.