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 Investigators Meetings
- Maintenance of study-specific automated tracking systems
- Preparation for and attendance at companys 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 drivers 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.
Remote Work :
No
Employment Type :
Full-time