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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 well-being and quality of data compliance.
This is a remote role.
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
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