Senior Clinical Research Associate

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

📋 Description

• Execute and coordinate activities related to clinical monitoring and site management.

• Carry out remote or on-site visits to evaluate adherence to protocols and regulatory standards.

• Oversee necessary clinical trial documentation and guarantee readiness for audits.

• Supervise investigator sites utilizing a risk-based monitoring methodology.

• Employ root cause analysis, critical thinking, and problem-solving techniques to pinpoint site process failures and devise corrective/preventive measures.

• Ensure the precision of data through SDR, SDV, and CRF evaluations.

• Review investigational product inventory and records.

• Record findings in reports and correspondence.

• Report deficiencies and monitor issues until they are resolved.

• Maintain communication with investigative sites between monitoring visits.

• Carry out supervisory responsibilities as outlined in the approved monitoring plan.

• Engage in investigator payments, meetings, follow-ups on findings, and project-related tasks.

• Identify potential investigators and initiate clinical trial sites.

• Conduct trial close-out procedures and retrieve trial materials.

• Confirm that essential documents are complete and adhere to ICH-GCP and regulatory requirements.

• Perform on-site file evaluations.

• Provide updates on trial status and progress reports to the Clinical Team Manager.

• Revise clinical study systems, including the Clinical Trial Management System.

• Enhance communication among investigative sites, the client organization, and the PPD project team.

• Address company, client, and regulatory requests, audits, and inspections.

• Finalize expense reports and timesheets.

• Contribute to project publications, tools, and initiatives for process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or an equivalent relevant formal academic/vocational qualification.

• Around 1 year of experience as a clinical research monitor.

• Demonstrated clinical monitoring capabilities.

• Familiarity with medical/therapeutic areas and medical terminology.

• Knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Proficient in critical thinking, root cause analysis, and problem-solving.

• Ability to manage risk-based monitoring principles and processes.

• Strong oral and written communication abilities.

• Customer-oriented with excellent listening skills, attention to detail, and capability to identify underlying issues.

• Organizational and time management proficiency.

• Strong interpersonal skills.

• Flexibility and adaptability.

• Capability to work independently or collaboratively within a team.

• Proficient in Microsoft Office and the ability to learn relevant software.

• Good command of the English language and grammar.

• Effective presentation skills.

• Australian citizenship or permanent residency is required.

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Wellness programs.

• Employee Assistance Program.

• Flexible work arrangements.

• Generous leave policies.

• Option to purchase additional leave.

• Paid birthday leave.

• Company-paid parental leave.

• Paid volunteer time.

• Access to online courses through Thermo Fisher Scientific University Plus and LinkedIn Learning.

• Participation in workshops and mentorship programs.

• Annual incentive plan bonus.

• Employee benefits.

• Competitive remuneration.