Senior Clinical Research Associate II – UK

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the primary CTI liaison for designated study sites.

• Execute pre-study assessments, site initiation, interim monitoring, and site closure visits.

• Fulfill site visit obligations in accordance with the Monitoring Plan and stipulated timelines.

• Aid in or supervise study initiation, feasibility assessments, pre-study tasks, and site selection processes.

• Gather, assess, and maintain essential and regulatory documentation.

• Engage in mandatory training sessions and meetings with investigators, clients, and project teams.

• Develop and implement strategies for subject enrollment at assigned sites.

• Ensure the appropriate storage, distribution, and accountability of investigational products and trial-related resources.

• Carry out site management tasks and provide updates on site status to the Clinical Project Manager.

• Conduct remote monitoring in line with the study-specific Monitoring Plan.

• Utilize systems and reports to monitor subject status, retrieve CRFs, review source documents, and track regulatory documents and investigational products.

• Contribute to project-specific tasks as a member of the Project Team.

⛳️ Requirements

• 3–5 years of experience in clinical research as a CRA or in a related field.

• Background in life sciences.

• Strong understanding of ICH-GCP and regulatory standards.

• Capability to conduct pre-study, site initiation, interim monitoring, and close-out visits.

• Competence in completing site visit deliverables within required timelines.

• Familiarity with relevant regulatory requirements, SOPs, and ICH GCP guidelines.

• Ability to assist in or oversee study start-up, feasibility assessments, pre-study tasks, and site selection.

• Proficiency in collecting, reviewing, and tracking essential and regulatory documents.

• Capacity to fulfill required general and study-specific training.

• Ability to participate in meetings with investigators, clients, and project teams, including making presentations.

• Skill in creating and implementing strategies for subject enrollment.

• Capability to manage investigational products and trial-related materials.

• Proficiency in performing site management and remote monitoring tasks.

• Ability to utilize systems and reports for tracking subject status, CRF retrieval, source document review, regulatory documents, and investigational products.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing education support.

• Hybrid work opportunities.

• CTI Cares community and global giving initiatives.

• Opportunities to work on the development of life-changing treatments.