Senior CRA - IVD Devices (Travel)

ARC Regulatory Ltd.; Belfast City District; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

ARC Regulatory Ltd. in Belfast seeks a Clinical Site Monitor to visit and remotely assess in vitro diagnostic medical device clinical study sites, ensuring compliance with the study protocol, ICH GCP and local regulatory requirements.

The role involves qualification of sites, initiation, monitoring and close-out activities, and frequent collaboration with sponsors and ethics committees. Candidates should have a Life Sciences degree or equivalent, at least 5 years in Clinical Research with 3+

Qualifications

• Life Sciences degree or equivalent required.
• Current ICH-GCP certification required.
• Minimum 5 years in Clinical Research with ≥3 years monitoring medical device trials.

Responsibilities

• Monitor in vitro diagnostic clinical study sites per protocol and regulatory requirements.
• Qualify investigational sites, initiate, monitor and close-out visits.
• Prepare monitoring reports and data trackers in a timely manner.
• Coordinate with ethics committees and sponsor for approvals and reporting.
• Train site personnel on study protocols and case report forms.

Skills

ICH-GCP knowledge

Data verification

Site monitoring

Regulatory compliance

Effective communication

Education

Life Sciences Degree or equivalent

Current ICH GCP certification

Job description

ARC Regulatory Ltd. in Belfast seeks a Clinical Site Monitor to visit and remotely assess in vitro diagnostic medical device clinical study sites, ensuring compliance with the study protocol, ICH GCP and local regulatory requirements.

The role involves qualification of sites, initiation, monitoring and close-out activities, and frequent collaboration with sponsors and ethics committees. Candidates should have a Life Sciences degree or equivalent, at least 5 years in Clinical Research with 3+