Senior Clinical Research Associate

This is a fully remote position, open to applicants in Australia.

📋 Description

• Manages all facets of study site operations to safeguard patient safety, ensure high-quality data from sites, resulting in consistently low query levels and satisfactory Quality Assurance reports.

• Provides direction at both the site and project levels to meet audit readiness standards and assists in preparing for audits and necessary follow-up actions.

• Updates, monitors, and maintains trial management tools/systems and status reports specific to the study.

• When necessary, oversees site start-up processes, including assessing and recruiting potential investigators, preparing EC/IRB submissions, collecting and reviewing regulatory documents, adapting Patient Informed Consents, notifying IRB, EC, and regulatory authorities as needed, translating study-related documents, organizing meetings, and executing other tasks as directed by the Clinical Trial Manager/Project Manager.

• Conducts all types of site visits independently, including pre-study/qualification, initiation, routine monitoring, and close-out visits, adhering to the protocol, local regulations, ICH-GCP, and Precision SOPs.

• Records activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documentation in accordance with SOPs, the Clinical Monitoring Plan/Site Management Plan, and client specifications.

• Engages effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to communicate protocol/study issues, including any deviations, and implements necessary corrective actions.

• Cultivates and sustains positive working relationships with investigators and study staff, acting as an ambassador to uphold Precision's high-quality professional reputation.

• Conducts inventory management, reconciliation, and reviews of investigation product (IP) storage and security.

• Executes data review tasks, including remote EDC CRF and patient profile reviews, query resolution, and collaborates with data management and clinical data quality teams to address data discrepancies.

• Prepares for and participates in Investigator Meetings and/or face-to-face meetings with sponsors.

⛳️ Requirements

• Bachelor’s degree or international equivalent, or a comparable combination of education and experience, preferably in a business, scientific, or healthcare field.

• At least 3 years of on-site monitoring experience; 2 years of oncology and Phase I experience is preferred.

• High proficiency in Microsoft Office applications (Outlook, Word, Excel, and PowerPoint).

• Customer service-oriented demeanor, demonstrating flexibility and the ability to work collaboratively.

• Capacity to maintain focus on details over extended periods, with a strong emphasis on accuracy.

• Proficient in English communication, both verbal and written.

• Familiarity with the drug development process.

• Willingness to travel (60-70%).

🏝️ Benefits

• Precision for Medicine is not your typical CRO.

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Opportunities for professional development.