Clinical Research Associate I - Sydney based

Job Overview

This role involves overseeing site monitoring and site management responsibilities for open-label clinical studies, complying with company, sponsor SOPs, and regulatory standards. The incumbent ensures successful implementation of project plans assigned.

Key Duties

• Manage all site monitoring duties including routine and closeout visits, maintenance of study documentation, pre-study and initiation visits, and vendor coordination.
• Conduct comprehensive site management tasks as outlined in project plans.
• Carry out on-site monitoring activities ensuring study personnel are adequately prepared and trained to recruit subjects safely adhering to protocol.
• Safeguard patient welfare by verifying informed consent and compliance with protocol and regulatory requirements.
• Maintain data integrity through rigorous review of source documents and verification of case report forms or other data collection methods.
• Detect and address missing or questionable data points.
• Optimize utilization of sponsor and company resources by executing monitoring functions efficiently under SOPs and guidelines; manage travel costs aligning with company travel policy.
• Ensure site audit readiness at all times.
• Obligatory travel, including air travel, is part of this role.
• Generate precise and prompt trip monitoring reports.
• Collaborate with internal teams to assess needs, allocate resources, and track project timelines.
• Serve as liaison for clinical trial supplies and vendor management as designated.
• Manage registry-related tasks per project specifications.
• Engage in feasibility assessments upon request.
• Participate and provide feedback on Quality Control Visits as needed.
• Support recruitment of investigators, prepare ethics committee submissions, facilitate regulatory notifications, translate study documents, schedule meetings, and execute additional supervisor-assigned tasks.
• Aid Senior CRAs with investigator site budget management.
• Monitor and follow up on Serious Adverse Events including report generation and narrative documentation.
• Independently review case report forms, generate and resolve queries based on established data review procedures utilizing company or client data management systems.
• Assist in training, mentoring, and developing junior staff through co-monitoring activities.
• Coordinate clinical projects locally as a project coordinator under supervision and may act as client contact when assigned.
• Perform other duties as assigned by management.

Basic Qualifications

• Degree or certification from an accredited institution in an allied health field (e.g., nursing license); equivalent relevant experience may be considered as a substitute.
• Fundamental knowledge of regulatory guidelines and clinical trial processes.
• Fluency in English and local office language, both written and spoken.

Experience Requirements

• At least six months’ experience in related positions such as site management, in-house clinical research associate, study coordination, or research nursing.
• Good collaborative skills to function effectively within project teams.
• Strong planning, organizational, and problem-solving abilities.
• Proficient computer skills with familiarity across multiple software packages.
• Ability to perform efficiently in a matrix organizational environment.
• Possession of a valid driver’s license and readiness to travel interstate for onsite monitoring inspections.

Additional Information

Travel including flights is a necessary part of this job. Equal Employment Opportunity and accommodation policies apply.