Senior Clinical Research Associate, Cell & Gene – FSP

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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 source document review, source data verification and CRF review during on-site and remote monitoring • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution and timely data recording • Conduct supervising tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Identify potential investigators and initiate clinical trial sites in compliance with protocols, regulations and ICH GCP obligations • Perform trial closeout and retrieve trial materials • Ensure crucial documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • Assist with project publications and tools and contribute ideas to the project team • Contribute to other project work and process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or an equivalent relevant academic or vocational qualification • At least one year of experience as a Clinical Research Monitor • Mandatory experience in Cell and Gene Therapy (CGT) • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills • Ability to communicate effectively with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work in a team or independently • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • 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-paid parental leave • Paid volunteer time • Thermo Fisher Scientific University Plus online courses • LinkedIn Learning • Workshops • Mentorship programs • Annual incentive plan bonus • Employee benefits • Career and development prospects

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