Clinical Research Associate II

1 month ago

København, Denmark Psi CRO Ag Full time

PSI is a leading Contract Research Organisation with nearly 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.

Job Description

As a CRA II, 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, well-being, and quality of data compliance.

Home-based position from anywhere in Denmark

Your responsibilities will include:

  • 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
Qualifications
  • Degree in Life Sciences (or similar), or an equivalent combination of education, training & experience
  • At least 2-3 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
  • As you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel
  • 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. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.

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