Clinical Research Associate II – FSP

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

📋 Description

• Oversee investigator sites utilizing a risk-based monitoring strategy

• Utilize root cause analysis, critical thinking, and problem-solving skills to pinpoint site process failures and implement corrective and preventive measures

• Ensure data integrity through SDR, SDV, and CRF evaluations during both on-site and remote monitoring

• Evaluate investigational products via physical inventory checks and record assessments

• Record observations in timely reports and correspondence

• Raise deficiencies and issues to clinical management and ensure they are addressed until resolved

• Maintain communication with investigative sites between monitoring visits

• Execute monitoring tasks in alignment with the approved monitoring plan

• Engage in investigator payments and meetings

• Identify potential investigators and qualified investigative sites for the client company

• Initiate clinical trial sites in accordance with protocol, regulatory, and ICH GCP requirements

• Conduct trial closeout procedures and retrieve trial materials

• Ensure that essential documents are complete and organized

• Perform on-site file assessments

• Provide tracking of trial status and progress updates to the Clinical Team Manager

• Update study systems, including the Clinical Trial Management System

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

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

• Complete administrative tasks such as expense reporting and timesheet management

• Support project publications and tools

• Contribute to project work and initiatives aimed at process improvement

⛳️ Requirements

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

• Valid driver's license, where applicable

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

• A combination of relevant education, training, and/or directly related experience may be considered equivalent

• Demonstrated clinical monitoring capabilities

• 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

• Proficiency in managing Risk-Based Monitoring concepts and processes

• Excellent oral and written communication skills, including interactions with medical personnel

• Customer-oriented with strong listening skills, attention to detail, and the ability to uncover underlying customer issues

• Strong organizational and time-management skills

• Effective interpersonal skills

• Adaptability and flexibility

• Capability to work independently or collaboratively within a team

🏝️ Benefits

• Comprehensive health and wellbeing 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

• Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning

• Workshops

• Mentorship programs