Are you ready to drive the future of clinical research? Looking to be in the heart of a company where precision meets purpose?
Proclinical is seeking a Clinical Research Associate to join our client and contribute to the successful execution of clinical trials. In this role, you will play a key part in ensuring compliance with protocols, regulatory guidelines, and Good Clinical Practice (GCP) standards. This position offers the flexibility of working from home while collaborating with investigational sites and project teams to deliver high-quality outcomes in oncology-focused clinical research.
Responsibilities:
- Conduct remote and on-site monitoring visits to ensure protocol and regulatory compliance.
- Perform source data review, source data verification and case report form review to ensure data accuracy.
- Assess investigational product inventory and records for compliance.
- Document observations and findings in reports and escalate issues as needed.
- Maintain regular communication with investigational sites to address protocol adherence and resolve issues.
- Participate in investigator meetings and assist in identifying qualified investigative sites.
- Initiate, monitor, and close out clinical trial sites according to approved procedures.
- Ensure essential documents are complete and compliant with ICH-GCP and applicable regulations.
- Provide trial status updates and maintain study systems as required.
- Facilitate effective communication between sites, clients, and project teams.
- Respond to audits, inspections, and regulatory requirements.
- Complete administrative tasks such as expense reports and timesheets promptly.
- Contribute to process improvement initiatives and project-related publications or tools.
Key Skills and Requirements:
- Background in life sciences or equivalent qualification (e.g., Registered Nursing certification).
- Experience in clinical research monitoring or relevant training.
- Therapeutic experience in oncology is essential.
- Strong understanding of ICH-GCP guidelines, medical terminology, and applicable regulations.
- Critical thinking and problem-solving skills, including root cause analysis.
- Proficiency in risk-based monitoring concepts and processes.
- Excellent communication, organizational, and time management skills.
- Ability to work independently and collaboratively within a team.
- Proficient in Microsoft Office and other relevant software.
- Australian citizenship or permanent residency is required.
If you are having difficulty in applying or if you have any questions, please contact Sam Rodriguez at s.rodriguez@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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