Clinical Research Associate II / Senior Clinical Research (CRA) - UK
CTI Clinical Trial and Consulting Services · GB
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About the Role
Serve as the main CTI contact for assigned study sites, conducting various site visits and assisting with study start-up activities. You will be responsible for collecting, reviewing, and tracking essential documents, participating in training, and attending meetings. Additionally, you will create and implement subject enrollment strategies, ensure proper management of Investigational Product, perform site management activities, and conduct remote monitoring. You will utilize systems to track subject status, CRF retrieval, and IP, and assist with project-specific activities as a member of the Project Team.
Responsibilities
- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings; may include presentations
- Create and implement subject enrollment strategies for assigned study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
Requirements
- 3 - 5 years clinical research experience as a CRA or related profession
- Life science background
- Excellent knowledge in ICH-GCP and regulatory requirements
Work Type
- hybrid work opportunities
Experience Level
- 3 - 5 years
Benefits
- Structured mentoring program
- Leadership development courses
- Dedicated training department
- Support for ongoing education
- Support for work-life balance
About the Company
- Advance Your Career – We invest in your professional growth.
- Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people.
- Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.