Terumo Aortic are looking for an organised and detail-driven In-House Clinical Research Associate to support the efficient, compliant delivery of clinical trials. In this role, you will oversee remote site management, centralised monitoring, data review and essential document management, working closely with investigative sites, internal study teams, vendors, Clinical Trial Administrators and external partners. This is a hybrid role with approximately 10% travel expected for site-related activity as required. This is an excellent opportunity to contribute to high-quality clinical trial delivery in a collaborative environment, supporting study oversight, data integrity, audit readiness and positive site relationships.

Key responsibilities

• Manage and oversee multiple clinical trial sites remotely, ensuring activities are delivered in line with study protocols, monitoring plans, GCP/ISO 14155 requirements and applicable regulations.
• Review enrolment trends, protocol deviations, data quality metrics and site KPIs to identify risks, trends and potential compliance concerns.
• Conduct remote monitoring and centralised monitoring activities, including review of study data, generation of monitoring reports and communication of findings and action items to sites.
• Review monitoring reports from field CRAs and CRO partners to support consistency, quality and compliance.
• Track and follow up on protocol deviations, Corrective and Preventive Actions, queries and outstanding site actions through to resolution.
• Review, maintain and quality check Trial Master File documentation, ensuring essential documents remain current and inspection ready.
• Perform regular reviews of data listings and dashboards, escalating missing, late or inconsistent data as appropriate.
• Act as a key liaison between trial sites, the study team and vendors, helping to resolve operational issues and maintain effective communication.
• Support site feasibility, qualification activities, recruitment oversight and site training.
• Provide guidance, task delegation and mentoring support to Clinical Trial Administrators, ensuring work is completed accurately, efficiently and to the required standard.

Essential experience and skills

• Bachelor’s degree in life sciences, medical sciences, nursing or a related field, or equivalent relevant experience.
• Strong working knowledge of clinical research requirements, including ISO 14155 and/or Good Clinical Practice.
• 3–5 years’ experience in clinical research, with 1–2 years’ monitoring experience preferred.
• Experience working with clinical trial management systems and electronic data capture systems.
• Strong written and verbal communication skills, with the ability to build effective relationships with site staff, study teams and vendors.
• Excellent attention to detail, organisational skills and ability to manage competing priorities.
• Confident problem-solving skills and a proactive approach to identifying and escalating risks.

Desirable experience

• Cardiovascular or Class III implantable medical device experience.
• Certification such as Certified Clinical Research Professional or Association of Clinical Research Professionals certification.
• 1–2 years’ experience in a lead or supervisory role.