Senior Clinical Research Associate II

🔥 6 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 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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