Lead Clinical Research Associate

About the role

PSI, a full-service Contract Research Organization with over 30 years of experience in the pharmaceutical industry, is hiring a Lead Clinical Research Associate in Sydney. The role is a leadership position within the study team, overseeing and guiding the clinical team and driving trial activities at country or regional level. It focuses on leadership, mentorship, oversight and consistent monitoring practice rather than direct site management, with minimal to no site assignments and a low-travel model.

Key responsibilities

• Monitor project timelines, patient enrollment, data cleaning and compliance, applying corrective and preventive measures
• Review monitoring visit reports and ensure reporting compliance of monitors in the region
• Act as the main communication link between Monitor, Site Management Associate, Regional Project Lead and Project Manager
• Lead project team calls, give status updates and report to the Regional Lead or Project Manager
• Provide project-specific training and prepare training materials under the supervision of a Project Manager and Regional Project Lead
• Supervise source data verification, follow up data queries, manage study risks and ensure data integrity at site level
• Ensure proper handling, accountability, reconciliation and return of investigational products and study supplies
• Review study documents, supervise reconciliation of the Investigator Site File and TMF, and coordinate safety information flow and protocol/process deviation reporting
• Manage Monitors in query resolution, coordinate planning and conduct supervised monitoring visits, and manage site contracting and payments
• Prepare site audit visits, take part in audits and coordinate resolution of audit findings
• Oversee CAPA development, process deviation review and reporting, and mentor newly promoted Lead CRAs
• Deliver trainings at investigator meetings, support draft regulatory and ethics submission packages, and ensure subject recruitment targets and timelines are met

Required profile

• Relevant education such as MD, MPharm, RN or a life sciences degree, or an equivalent combination of education, training and experience
• At least 4 years of site monitoring experience, including global clinical projects as a Lead Monitor or equivalent
• Experience with monitoring visits in Phase II and/or III studies
• Oncology, gastroenterology, infectious diseases, autoimmune diseases or rare disease experience is preferable
• Full working proficiency in English and ability to travel

Required skills

• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team
• Excellent communication, collaboration and problem-solving skills