Study Submissions Coordinator Role
We are seeking a dedicated and skilled Study Submissions Coordinator to join our team. This role will be instrumental in ensuring the successful activation of investigative sites across various phases of clinical trials.
About the Job
In this role, you will perform critical activities within the country that lead to site activation. This includes preparing, reviewing, and submitting regulatory applications to relevant agencies. You will also communicate with global study teams and personnel on study progress, identify risks to site activations, and provide expertise and guidance on ethics and regulatory submissions.
Responsibilities
* Prepare and submit regulatory applications to TGA and Medsafe.
* Communicate with global study teams and personnel on study progress.
* Identify and mitigate risks to site activations.
* Provide expertise and guidance on 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.
* Ensure submissions comply with applicable regulations and guidance documents.
* Advise sponsors on changing regulations and compliance requirements.
* Track submissions and ensure timely filing of documents.
Qualifications
* Bachelor's degree in a 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.
* 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.
What We Offer
* A competitive compensation and benefits package.
* A flexible work environment.
* Career advancement opportunities.
* Structured career paths with opportunities for professional growth.
About Us
We are a full-service clinical contract research organization (CRO) providing 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 our scientific and disciplined approach.