Lead Clinical Research Associate Location: Sydney or Melbourne
Job Type: Full-time -Contract
If you are passionate about clinical research and have a strong ability to manage and monitor clinical trials, we want to hear from you!
Overview:
As Lead CRA, you will play a critical role in monitoring the progress of clinical trials at investigative sites or remotely, ensuring compliance with protocols, SOPs, ICH-GCP guidelines, and all applicable regulatory requirements.
Key Responsibilities: Monitor local and global clinical trials to ensure compliance with sponsor and investigator obligations and ICH-GCP guidelines.Assess and qualify potential investigative sites, initiate clinical trials, and provide training to site personnel on trial conduct.Review and verify the accuracy of clinical trial data, either onsite or remotely, ensuring adherence to protocol.Provide regular updates to the clinical trial team and management, updating trial tracking systems and documents.Ensure proper handling and accountability of Investigational Products (IP), including dispensation and compliance at the investigative sites.Monitor and verify Serious Adverse Event (SAE) reporting in accordance with trial specifications and ICH-GCP guidelines.Conduct source document verification, query resolution, and reconcile essential trial documents at the site.Collaborate with cross-functional teams to resolve trial-related issues, escalating as needed to ensure timely resolution.Ensure all required training is completed and documented to comply with trial protocols and regulatory standards.Assist with logistical support for Investigator Meetings and other trial-related tasks as assigned by the Clinical Trial Manager (CTM).What we're looking for: Bachelor's degree in clinical, science, or health-related field, or equivalent work experience (such as registered nurse is acceptable).4+ years of local trial experience, with exposure to multinational and global trials.Ability to manage investigative sites effectively to ensure timely trial deliverables.Proficient in Microsoft Office applications and Clinical Trial Management Systems (CTMS), e-TMF, IVRS/IWRS, and Electronic Data Capture (EDC) platforms.Strong problem-solving and analytical skills with the ability to resolve trial-related issues in collaboration with various stakeholders. Why apply?
This is a fantastic opportunity to grow within a leading clinical research organization.
You'll be part of a dynamic and collaborative team, working on cutting-edge clinical trials that make a meaningful impact on healthcare worldwide.
If you meet the qualifications and are eager to advance your career in clinical research, apply today!
We celebrate diversity and are committed to creating an inclusive environment for all employees.
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