Senior Clinical Research Associate - IVD/Medical Device

HIRANI; Belfast City District; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

HIRANI is seeking a Clinical Site Monitor to oversee in vitro diagnostic device clinical studies, ensuring protocol adherence, ICH-GCP, and local regulatory compliance. The role involves site qualification, initiation, monitoring, and close-out across study sites, with both on-site and remote activities.

The ideal candidate has 5+ years in Clinical Research, including 3+ years monitoring medical device/IVD trials, and strong data verification skills along with GCP/GLP auditing experience.

Qualifications

• Life Sciences Degree or equivalent.
• At least 5 years’ experience in Clinical Research with minimum 3 years’ experience monitoring general Medical Device or IVD Medical Device clinical studies.
• Proven experience in all aspects of clinical study site monitoring from selection and start up to close out.
• Highly experienced in source document/data verification with a forensic ability to identify relevant issues in the integrity of study data.
• Significant experience in data query and protocol deviation resolution.
• Knowledge of local regulations governing medical device clinical research.
• Knowledge of clinical data management requirements.
• Expert knowledge of Good Clinical Practice; ICH-GCP and ISO 14155.
• Experience of Monitoring pivotal medical device/in vitro diagnostic medical device clinical studies
• Knowledge of monitoring Essential Study Documents
• Experience in presenting and training on study Protocol, Investigators’ Brochure and (e)Case Report Form user acceptance testing
• Writing and presenting Clinical Study Monitoring Plans, Ethics Committees & Submission process knowledge
• Knowledge of local Adverse and Serious Adverse Events reporting processes for medical device clinical studies
• Presenting and understanding Investigator and Site responsibilities
• Clear understanding of Informed Consent process and ongoing IC SDV
• Able to work flexibly as required to ensure business needs are met
• Valid Passport
• Current ICH GCP certification
• Previous oncology experience
• GCP and GLP Auditing
• US FDA BIMO inspection readiness preparation
• IVD and CDx Experience
• Manage Consent

Responsibilities

• Visit and remotely assess clinical study sites to ensure protocol, ICH-GCP and local regulatory compliance.
• Qualify investigational sites and oversee setup, initiation, monitoring and close-out.
• Complete training sessions with Project Leads.
• Identify and assess facility suitability for device study sites.
• Conduct site monitoring per protocol/risk-based monitoring plan.
• Coordinate with site on study personnel availability and visit dates.
• Provide written confirmation of visit date and agenda.
• Prepare and review detailed study monitoring reports.
• Provide detailed study data and communication trackers in a timely manner.
• Follow up on site and sponsor actions to close out.
• Present and train study protocols to research study teams.
• Collect all site documents for Sponsor records.
• Reconcile site regulatory binder with Sponsor Master File.
• Attend Investigator Meetings.
• Design and complete SDV case report forms.
• Coordinate with ethics committee on study continuation and annual reporting.
• Report to ARC Regulatory Project Lead to prioritise actions.
• Any other duties, within reason and capability, as determined by ARC Regulatory management.

Skills

Clinical Research

ICH GCP

Data Verification

Site Monitoring

Regulatory Knowledge

Education

Life Sciences Degree or equivalent

Job description

HIRANI is seeking a Clinical Site Monitor to oversee in vitro diagnostic device clinical studies, ensuring protocol adherence, ICH-GCP, and local regulatory compliance. The role involves site qualification, initiation, monitoring, and close-out across study sites, with both on-site and remote activities.

The ideal candidate has 5+ years in Clinical Research, including 3+ years monitoring medical device/IVD trials, and strong data verification skills along with GCP/GLP auditing experience.