Senior Clinical Research Associate

PSI CRO

5d•Remote

About The Position

PSI is a leading Contract Research Organisation with 30 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. 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. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance. This is a home-based position.

Requirements

BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
Independent on-site monitoring experience in the Netherlands
Demonstrable experience in all types of monitoring visits in Phase II and/or III
Strong written and verbal communication skills
Fluency in Dutch and English
Advanced knowledge of MS Office
Full and clean driver's license, and the ability to travel
Communication, collaboration, and problem-solving skills are essential
Ability to multitask and work in a dynamic team environment

Nice To Haves

Experience supporting Oncology studies is beneficial, but not essential

Responsibilities

Conducting and reporting all types of onsite monitoring visits
Driving the study startup phase (if applicable)
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