Clinical Research Associate

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.

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