Work Summary 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. Job Responsibilities 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. Qualification College/University degree in Life Sciences or an equivalent combination of education, training & experience; Experience in vaccine and covid-19 is preferred; Min. 5 years of independent on-site monitoring experience; Experience in all types of monitoring visits in Phase II and III; Participation in clinical projects as a Lead/Senior Monitor; Good knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is 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.
Адрес
Москва