Job Title: Clinical Research Monitor
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We are excited to be advertising clinical research monitoring roles within the region, supporting the execution of our clinical trial program.
We are looking for science-based graduates with a strong background in a professional discipline or specialty. Someone who is great at building relationships and has an eye for detail.
The ideal candidate will have responsibility as an individual contributor, working on projects that involve delivering and overseeing sites from start-up activities through to close-out activities.
This role offers a unique opportunity to work enterprise-wide across a number of different devices and therapies, driving recruitment strategies and ensuring patient retention.
The majority of time is spent delivering and overseeing the sites assigned to you in your projects, while adhering to policies.
A Day in the Life:
* Work directly as a monitor and site manager for the sponsor
* See entire clinical research protocol from start to end
* Support site assessment
* Help prepare ethics submission packages
* Help oversee clinical trial conduct at their respective chosen sites
* Conduct monitoring visits on site or remotely depending on the trial per protocol requirements
* Monitor progress of clinical trials at the site level or headquarters and ensure they are conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and other applicable regulatory requirements
* Develop and maintain liaison with clinical investigators, affiliated hospitals, and research institutions to initiate and expedite clinical studies on products with investigational new drug or medical device approval
* Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports
* May assist with design, development, and monitoring of clinical evaluation projects
* Train investigators and site personnel on the device use and protocol through conducting SIVs
* Implement and prepare the clinical development strategy as outlined by the Clinical Director and the project teams
* May contact and recommend qualified investigators to perform studies and initiate clinical trials
* Drive recruitment strategies at your sites
* Ensure recruitment and retention of patients
* Device management
* Support the site with on-time data entry
* See study execution through to study close-out