Senior Clinical Research Associate
CRA role in global medical device organisation for someone with 12 months experience. Large co. but small clinical research team in one therapy area THE COMPANY YOU WOULD BE JOINING This medical device organisation is dedicated to improving care for patients across the globe.
Their R&D group encompasses extensive knowledge of surgical technologies and what's required to deliver outstanding products to specialist doctors and surgeons. Their global team is knowledgeable and experienced and includes technical experts who collaborate to advance the science in this niche, specialty area. BENEFITS Free Parking Barista on site Onsite Gym with Classes Mothers Room Discounted Healthcare Discounted Shares program A culture driven by diversity and innovation Comprehensive on boarding programs to help you plan a smooth and successful transition.
You and your manager will develop a customized on boarding plan in which you work together to identify the information, resources and people who will be key to your success. Career progression WHAT YOU WILL BUILD & GROW This organisation is looking for a Senior Clinical Research Associate (SCRA) to monitor and manage studies for clinical trials across ANZ. This role will be the primary contact between study site staff and the organisation during clinical trials.
This position will assist with the identification and selection of investigators to undertake clinical studies. You will prepare documentation for Ethics Committee submissions and collect and maintain regulatory documentation. You will participate in investigator meetings and conduct site assessments and initiation visits, routine monitoring visits and study close-out visits.
You will ensure protocol compliance as well as compliance with relevant regulations, including ICH GCP/ISO 14155. You will ensure all adverse events are reported, followed up and reconciled against documentation. You will handle and document customer complaints and action them with the relevant team.
WHAT EXPERIENCE & SKILLS WILL BE CONSIDERED? At least 12 monthsâ€™ experience in a similar role with the medical device or pharmaceutical industries or in a CRO. Good working knowledge of ICH GCP/ISO 14155 guidelines and other regulatory guidelines relevant to clinical research in Australia.\ Knowledge of TGA regulations pertaining to clinical trials and adverse event reporting.
Qualifications in nursing, science or equivalent work experience. WHAT DO YOU DO NOW? Interested, please apply now or call Scott Della-Pietra on 02.9817.
0599, quoting reference number 2821. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence.
Only shortlisted candidates will be contacted..