Clinical Research Associate II

Summary

Join PSI, a leading Contract Research Organisation, as a CRA II and work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects. Build and maintain relationships with clinical sites and investigators, focusing on subjects’ rights, safety and well-being and quality of data compliance. This home-based position in Denmark requires conducting and reporting all types of onsite monitoring visits, driving the study startup phase, performing CRF reviews, and managing site communication. You will supervise study activities and act as a point of contact for support services. The role also involves supporting quality control, participating in feasibility research, and supporting regulatory submissions. PSI invests in its people and offers a straightforward recruitment process.

Requirements

• Degree in Life Sciences (or similar), or an equivalent combination of education, training & experience
• At least 2 years of experience conducting independent on-site monitoring visits, ideally on multiple projects at a time
• Demonstrable experience in all types of monitoring visits in Phase II and/or III
• Native/Fluent Danish and advanced English
• Strong written and verbal communication skills
• 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
• As you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel

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

Preferred Qualifications

Experience supporting Gastroenetreology studies is an asset