Clinical Research Associate II

Summary

Join PSI, a leading Contract Research Organisation, as a CRA II and work remotely on the frontline of communication with project stakeholders. You will ensure timelines, targets, and standards of clinical research projects across various therapeutic indications. Responsibilities include conducting monitoring visits, driving study startup, performing CRF reviews, managing site communication, supervising study activities, and supporting quality control and regulatory submissions. This role requires a BSc or MSc in Life Sciences or equivalent, on-site monitoring experience in the UK, and strong communication skills. Experience with Oncology studies and advanced MS Office skills are beneficial. A full and clean driver's license is essential for travel to multiple sites.

Requirements

• BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in the UK, ideally on multiple projects at a time
• Demonstrable experience in all types of monitoring visits in Phase II and/or III
• 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 Oncology studies is beneficial, but not essential

Benefits

• This is a remote role
• We will guide and support you with information, making your experience as smooth as possible
• Join the company that focuses on its people and invests in their professional development and success