Clinical Research Associate

ARC Regulatory; Newtownabbey; On-site; GBP 50,000 - 65,000; Full time

Job summary

ARC Regulatory is seeking an experienced Clinical Research Associate to monitor in vitro diagnostic clinical study sites, ensuring compliance with the study protocol, ICH GCP and local regulations. The role involves site qualification, initiation, monitoring, and close-out visits across Belfast and travel as required.

The successful candidate will bring 5+ years in clinical research, with at least 3 years focused on medical device/IVD trials, expertise in SDV, data integrity and regulatory

Qualifications

• Minimum 5 years’ experience in Clinical Research with at least 3 years monitoring medical device/IVD studies.
• Proven expertise in source data verification and data integrity.
• Strong knowledge of ICH-GCP, ISO 14155 and local regulations.
• Experience with trial site qualification, initiation, monitoring and close-out.
• Excellent training, communication and report-writing skills.

Responsibilities

• Perform site qualification, initiation, monitoring and close-out per protocol.
• Carry out site visits (onsite or remote) and develop monitoring plans.
• Prepare and review detailed monitoring reports and data trackers.
• Coordinate with ethics committees and regulatory submissions.
• Train site staff on study protocols and CRF completion.
• Maintain sponsor Master File alignment and site paperwork.

Skills

Clinical Research

Site Monitoring

ICH GCP / ISO 14155

Data Verification / SDV

Regulatory Knowledge

IVD/Medical Device knowledge

Education

Life Sciences Degree

Job description

Clinical Research Associate

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

NB: We also welcome applications from candidates with a laboratory, medical, nursing, or wider clinical background. Full training and development will be provided to support successful candidates in transitioning into the Clinical Research Associate role.

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