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.
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
#J-18808-Ljbffr
Clinical Research Associate employer: HIRANI
HIRANI is an exceptional employer located in Belfast, offering a dynamic work culture that fosters innovation and collaboration in the healthcare sector. Employees benefit from comprehensive professional development opportunities and a supportive environment that encourages growth and creativity, making it an ideal place for those passionate about leveraging Data and AI to drive meaningful change in healthcare.
