Location: Belfast / requires travel when required

Job Purpose:
Act in the role of clinical site monitor to regularly visit/remotely assess in vitro diagnostic medical device clinical study sites and ensure that the study is conducted in compliance with the study protocol, ICH GCP and local regulatory requirements.

Key Responsibilities:

• The CRA will be involved in all aspects of the in vitro diagnostic clinical trial, including qualification of investigational sites as well as setting up, initiating, monitoring and close-out of assigned study sites. The CRA will be required to carry out the following duties at clinical investigation sites:
• Complete appropriate training sessions with Project Leads
• Identify and assess the suitability of facilities to be used as the device study/investigation site
• Conduct site monitoring in accordance with the study protocol/risk-based site monitoring plan
• Liaise with site to agree study personnel availability and visit date
• Provide written confirmation of visit date and agenda
• Prepare and review detailed study monitoring reports
• Provide detailed study data and communication trackers in timely manner (as per protocol/monitoring plan)
• 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 the 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.

Essential Criteria:

• 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

Desirable Criteria

• Current ICH GCP certification
• Previous oncology experience
• Site pre-qualification experience
• GCP and GLP Auditing
• US FDA BIMO inspection readiness preparation
• IVD and CDx Experience

“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”