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 close to 3,000 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 visitsSupporting quality control, such as compliance monitoring and reports reviewContact for clinical investigators, vendors and support services in regard to study progressDelivering training of investigators, site staff and project teamsBe involved in site identification process and feasibility researchSupport to Regulatory Affairs in procurement of site regulatory documentsPreparation and delivering of presentations at Investigator’s MeetingsMaintenance of study-specific automated tracking systemsPreparation for and attendance at company’s audits; resolution of audit findings

QualificationsDegree in Life Sciences (or similar), or an equivalent combination of education, training & experience1 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 IIINative Bulgarian and full working proficiency in EnglishExperience supporting Oncology studies is beneficial, but not essentialProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAs 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.