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 and wellbeing and quality of data compliance.
Homebased 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 inhouse 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 23 years of experience conducting independent onsite 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
- As you will be monitoring multiple sites you must have a full and clean drivers license and the ability to travel
- Communication collaboration and problemsolving skills are essential
Remote Work :
No
Employment Type :
Contract