Experienced Study Start up Submissions Coordinator

at  Medpace Inc

Job Summary :
We are currently seeking a full-time Study Start up Submissions Coordinator 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. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.
Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.

Responsibilities :

• 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);
• Communicate with global study teams and personnel on study progress;
• 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;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors on changing regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents.

Qualifications :

• Bachelor’s degree in the science field or equivalent combination of education and experience;
• At least 4 year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
• Experience in preparing and submitting TGA regulatory applications;
• Excellent organization and communication skills;
• 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; including formulating responses to queries; and
• Proactive approach to role with ability and willingness to learn and be challenged.

Medpace Overview :
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. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace? :
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

• 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);
• Communicate with global study teams and personnel on study progress;
• 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;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors on changing regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents