Senior Clinical Research Associate – FSP

🔥 2 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

• Perform and coordinate all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required documentation and sponsor/monitoring-environment procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure audit readiness and develop relationships with investigational sites • 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 reports and letters using approved business writing standards • Escalate deficiencies and issues to clinical management and follow through to resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in the investigator payment process • Investigate and follow up on findings • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform required CTMS report quality-control checks • Participate in investigator meetings • Identify potential investigators with the client company • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and in place; conduct on-site file reviews • Contribute to project publications, tools and process-improvement initiatives • Perform additional study tasks assigned by the CTM • Facilitate communication between investigative sites, client company and PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Frequent travel to site locations, generally 60–80% or more

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification • Valid driver's license where applicable • 3+ years as a clinical research monitor, or comparable experience providing the required knowledge, skills, and abilities • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and demonstrated application 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 • Effective oral and written communication skills with medical personnel • Customer focus, listening skills, attention to detail and ability to perceive underlying customer issues • Effective interpersonal skills • Strong attention to detail • Ability to comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information

🏖️ Benefits

• Comprehensive health and wellbeing benefits • Wellness programs • Employee Assistance Program providing confidential support for personal and work-related issues • Flexible arrangements • Generous leave policies • Option to purchase additional leave • Paid birthday leave • Company paid parental leave • Paid volunteer time • Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning • Workshops and mentorship programs • Employer recognized by WGEA as an Employer of Choice for Gender Equality