Senior Clinical Research Associate IVD Medical Devices

ARC Regulatory; Lisburn; On-site; GBP 50,000 - 74,000; Full time

Job summary

ARC Regulatory in Belfast is seeking a Clinical Research Associate to monitor in vitro diagnostic device clinical sites, ensuring compliance with the study protocol, ICH GCP, and local regulations. The role involves site qualification, initiation, monitoring, and close-out activities, with occasional travel.

You will prepare detailed monitoring reports, manage study data, liaise with ethics committees, and train site study teams.

Qualifications

• Life Sciences degree or equivalent.
• At least 5 years in Clinical Research with minimum 3 years monitoring device or IVD trials.
• Proven experience in site monitoring from start-up to close-out.
• Strong knowledge of ICH-GCP, ISO 14155 and local regulations.

Responsibilities

• Monitor clinical investigation sites per protocol and monitoring plan.
• Qualify investigational sites and manage start-up to close-out.
• Prepare monitoring reports and data trackers in a timely manner.
• Coordinate with ethics committees and sponsor on submissions.
• Present study protocols and train site teams.

Skills

Source data verification

Protocol deviations

Regulatory knowledge

GCP knowledge

Training others

Education

Life Sciences degree or equivalent

Job description

ARC Regulatory in Belfast is seeking a Clinical Research Associate to monitor in vitro diagnostic device clinical sites, ensuring compliance with the study protocol, ICH GCP, and local regulations. The role involves site qualification, initiation, monitoring, and close-out activities, with occasional travel.

You will prepare detailed monitoring reports, manage study data, liaise with ethics committees, and train site study teams.