Clinical Research Associate I

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

📋 Description

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

• Perform both remote and on-site visits to evaluate adherence to protocols and regulatory standards.

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

• Utilize a risk-based monitoring strategy to supervise investigator sites.

• Conduct root cause analysis and formulate corrective and preventive measures.

• Ensure the integrity of data through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) assessments.

• Evaluate investigational products by reviewing inventory and records.

• Record findings in reports and letters, and escalate issues until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring responsibilities as outlined in the approved monitoring plan.

• Participate in investigator compensation and meetings.

• Identify and initiate engagement with qualified investigative sites.

• Conduct trial closure and retrieve trial materials.

• Ensure the completeness of essential documents and carry out on-site file audits.

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

• Update study systems, including Clinical Trial Management Systems.

• Facilitate communication between investigative sites, the client company, and the PPD project team.

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

• Complete expense reports and timesheets.

• Assist with project publications and tools while contributing to process enhancement initiatives.

⛳️ Requirements

• Bachelor’s degree in a life sciences discipline, Registered Nursing certification, or an equivalent relevant academic/vocational qualification.

• Valid driver’s license if applicable.

• Prior experience of approximately 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Equivalence may be established through a combination of relevant education, training, and/or related experience.

• Demonstrated skills in clinical monitoring.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, relevant regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Proficient oral and written communication skills.

• Strong organizational and time management skills.

• Effective interpersonal abilities.

• Keen attention to detail.

• Adaptability and flexibility.

• Ability to work collaboratively as part of a team or independently.

• Frequent travel expected, generally 60–80%, including regular drives to site locations and possible extended overnight stays.

• Capacity to work in office, laboratory, clinical, and/or home office settings.

• Ability to utilize required personal protective equipment.

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Wellness initiatives.

• Employee Assistance Program.

• Flexible working arrangements.

• Generous leave policies.

• Option to purchase additional leave.

• Paid birthday leave.

• Company-sponsored parental leave.

• Paid time for volunteering.

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

• Workshops and mentorship programs.

• Recognized as an Employer of Choice for Gender Equality.