Senior Clinical Research Associate II

• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring
• Assess investigational product through physical inventory and records review
• Document observations in timely reports and letters
• Escalate deficiencies and issues to clinical management and follow them through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and qualified investigative sites with client collaboration
• Initiate clinical trial sites in compliance with protocols, regulations and ICH GCP obligations
• Ensure trial closeout and retrieval of trial materials
• Maintain essential documents and conduct on-site file reviews
• Mentor new project team members and assist with project publications, informed consents, CRF guidelines and monitoring plans
• Assist with clinical team training and identify process improvement opportunities
• Perform additional tasks assigned by CTM or CM-CRA
• Provide trial status tracking and progress updates to the CTM
• Update study systems including CTMS and perform required quality-control checks
• Facilitate communication between investigative sites, the client company and the PPD project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Travel frequently to site locations, generally 60–80%, with possible extended overnight stays

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• Valid driver's license where applicable
• Previous experience comparable to 3+ years as a clinical research monitor
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Effective clinical monitoring skills
• Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking, root cause analysis and problem-solving skills
• Knowledge of Risk Based Monitoring concepts and processes
• Ability to mentor and train other monitors
• Ability to evaluate medical research data and knowledge of medical terminology
• Effective oral and written communication skills with medical personnel
• Customer focus, listening skills and attention to detail
• Effective organizational and time management skills
• Flexibility and adaptability
• Effective presentation skills
• Willingness and ability to travel frequently, generally 60–80%
• Ability to work in office/laboratory/clinical/home office environments
• Ability to use required personal protective equipment
• Ability to work with potential exposure to biological fluids and infectious organisms

• Relocation assistance may be available for experienced candidates relocating from interstate or NZ
• An attractive sign-on bonus may be offered as part of a competitive remuneration package
• Comprehensive health and wellbeing benefits
• Wellness programs
• Employee Assistance Program providing confidential support
• 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 and mentorship programs
• WGEA Employer of Choice for Gender Equality