Industry: Medtech, Digital Health.
Job Functions: Site Monitoring for clinical trials with medical device.
Location: Australia.
Workplace: remote/availability to travel.
Meditrial is seeking a certified Clinical Research Associate (CRA) with extensive experience in medical device clinical trials to join our dynamic team. The CRA will be responsible for monitoring Phase I-IV clinical trials, ensuring compliance with Good Clinical Practices (GCP) and study protocols. This role involves conducting site evaluations, initiation, interim, and close-out visits, as well as collaborating closely with Clinical Project Managers and CTAs.
The ideal candidate will have a proven track record in medical device trials, particularly in cardiology, and must be available to travel for monitoring activities as needed.
Responsibilities
* Conduct on‐site and remote monitoring visits from SIV (Site Initiation Visit) to COV (Close‐Out Visit), ensuring study sites adhere to protocols and regulatory requirements.
* Train investigators and site personnel on study protocols and best practices.
* Review Case Report Forms (CRFs) and verify entries against source documentation.
* Document site visits, findings, and follow‐ups in detailed reports.
* Facilitate communication among investigative sites, sponsors, and internal teams.
* Identify and assess potential investigators in collaboration with sponsors.
* Ensure compliance with FDA, ICH‐GCP, and local regulatory guidelines.
* Assist in study submissions and preparation of regulatory documents.
* Support project teams with study communications and trial management activities.
Qualifications
* 6+ years of experience in clinical trial monitoring for CROs and Sponsors, with a strong focus on medical device trials.
* Expertise in cardiology trials and experience across other therapeutic areas.
* Higher or specialized degree in natural sciences (e.g., Biology, Medicine, Pharmacy, or related fields).
* CRA Certification with a track record of successful monitoring visits.
* Proficiency in electronic CRF (eCRF), CTMS systems, and other digital tools.
* Background in CROs, pharmaceuticals, biotechnology, and medical devices.
* Fluency in English.
* Willingness to travel as required for site visits and monitoring activities.
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