Senior Clinical Research Associate, Cell & Gene – FSP

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

📋 Description

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

• Implement root cause analysis, critical thinking, and problem-solving to pinpoint site process failures and determine corrective/preventive actions.

• Ensure the integrity of data through source document review, source data verification, and CRF examination during both on-site and remote monitoring.

• Evaluate investigational product inventory and records.

• Record observations in reports and correspondence, while escalating deficiencies to clinical management.

• Maintain communication with investigative sites between monitoring visits to verify protocol adherence, resolve issues, and ensure timely data entry.

• Execute supervisory tasks as per the approved monitoring plan.

• Engage in investigator payment processes and participate in investigator meetings.

• Identify prospective investigators and initiate clinical trial sites in alignment with protocols, regulations, and ICH GCP obligations.

• Conduct trial closeout and retrieve trial materials.

• Ensure the completeness of essential documents and perform on-site file reviews.

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

• Update study systems, including Clinical Trial Management Systems.

• Foster communication among investigative sites, the client company, and the PPD project team.

• Address company, client, and regulatory demands, including audits and inspections.

• Complete expense reports, timesheets, and other administrative duties.

• Support project publications and tools, while contributing ideas to the project team.

• Contribute to additional project work and process enhancement initiatives.

⛳️ Requirements

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

• Minimum of one year of experience as a Clinical Research Monitor.

• Essential experience in Cell and Gene Therapy (CGT).

• Demonstrated clinical monitoring expertise.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Knowledge of ICH GCPs, relevant regulations, and procedural documentation.

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

• Capability to manage Risk Based Monitoring concepts and processes.

• Excellent oral and written communication skills.

• Proficient in effective communication with medical personnel.

• Customer-oriented with strong listening skills and attention to detail.

• Solid organizational and time management skills.

• Strong interpersonal skills.

• Flexibility and adaptability.

• Ability to collaborate within a team or work independently.

• Proficient in Microsoft Office and capable of learning relevant software.

• Strong English language proficiency and grammar skills.

• Good presentation abilities.

• Australian citizenship or permanent residency required.

🏝️ 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-sponsored parental leave.

• Paid volunteer time.

• Access to Thermo Fisher Scientific University Plus online courses.

• LinkedIn Learning.

• Workshops.

• Mentorship programs.

• Annual incentive plan bonus.

• Employee benefits.

• Career and development opportunities.