As a Senior CRA 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.
Office-Based or Home-based
You will:
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup (if applicable)
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Supervise study activities, timelines, and schedules on the country level
- Be a point of contact for in-house support services and vendors
- Be involved in quality control, such as compliance monitoring and reports review
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in USA (5 years minimum)
- Experience in all types of monitoring visits in Phase II and/or III
- Participation in clinical projects as a Lead/Senior Monitor
- Experience monitoring complex Oncology (breast cancer) trials required
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
- Valid driver’s license (if applicable)
Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.