In-House Clinical Research Associate

Terumo Aortic; Inchinnan; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

Terumo Aortic are seeking an organised In-House Clinical Research Associate to support compliant delivery of clinical trials. You will oversee remote site management, centralised monitoring, data review and essential document management, collaborating with investigative sites, study teams, vendors and external partners.

Hybrid role with around 10% travel for site-related activity. The ideal candidate has a life sciences degree and 3–5 years' clinical research experience with monitoring exposure,

Qualifications

• Bachelor's degree in life sciences or related field.
• Solid knowledge of GCP/ISO 14155 and clinical research requirements.
• 3–5 years in clinical research with 1–2 years of monitoring experience preferred.

Responsibilities

• Oversee remote site management and centralised monitoring activities.
• Review enrolment trends, data quality metrics and site KPIs.
• Conduct remote monitoring and centralised monitoring and share action items.
• Review monitoring reports from field CRAs and CRO partners.
• Track protocol deviations and CAPAs through to resolution.
• Maintain and quality check Trial Master File documentation.
• Review data listings and dashboards, escalate data issues.

Skills

Clinical research

GCP/ISO 14155 knowledge

Monitoring experience

CTMS experience

EDC experience

Communication skills

Attention to detail

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

EDC systems

Job description

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.