Senior Clinical Research Associate I

Company Description

PSI is a leading Contract Research Organisation with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Senior CRA I, 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. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.

Your responsibilities will include:

• Conducting and reporting all types of onsite monitoring visits
• Performing CRF reviews, source document verification and query resolution
• Be responsible for site communication and management
• Supervising study activities, timelines, and schedules for each site
• Acting as a point of contact for in-house support services and vendors
• Supporting quality control, such as compliance monitoring and reports review
• Participating in feasibility research
• Supporting the regulatory team in preparing documents for study submissions and regulatory approval
• Driving the study startup phase (if applicable)

Qualifications

• BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in the Czech Republic, ideally on multiple projects at a time
• Demonstrable experience in all types of monitoring visits in Phase II and/or III
• Fluency in Czech and English
• Full and clean driver's license, and the ability to travel
• Experience supporting Oncology studies is beneficial
• Intermediate to Advanced knowledge of MS Office
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills are essential

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.