Education Consultant

1 month ago


Richmond QC, Canada Medpace, Inc. Full time

We are currently seeking a full-time, office-based Study Start up Submissions Coordinator Entry to join our Clinical Operations team in the Australia, Melbourne office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
Prepare, review, and submit to Regulatory Agencies (TGA / Medsafe);
Ability to effectively identify risks to site activations and mitigate as necessary;
Provide expertise and guidance to global study teams in ethics and regulatory submissions;
Review and finalize essential documents required for site activation;
Act as a main contact for Ethical and Regulatory submission-related activities;
Direct contact with investigative sites during the study start up and activation process;
Bachelor's degree in the science field or equivalent combination of education and experience;
At least 1 year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
Experience in preparing and submitting TGA regulatory applications;
Knowledge of Microsoft® Office;
Knowledge of ICH - GCP guidelines and regulatory guidelines in Australia and New Zealand;
Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
On-site fitness center(s)
Company-sponsored social and wellness events
Hybrid work-from-home options and flexible work schedule
On-site Market Place
Discounts for local businesses
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
EO/AA Employer M/F/Disability/Vets
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