About the role

As a Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop team-oriented relationships with investigational sites.

Key responsibilities

- Monitor investigator sites with a risk-based monitoring approach; apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks
- Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters in a timely manner using approved business writing standards
- Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
- Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner




- Conduct monitoring tasks in accordance with the approved monitoring plan
- Participate in the investigator payment process and ensure shared responsibility with other project team members on issues/findings resolution
- Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
- Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations

About you

- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Valid driver's license where applicable
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset,



in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues

Benefits

- Comprehensive health and wellbeing benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues
- Flexible work arrangements to balance work and personal life
- Generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave
- Paid volunteer time to support non-profit organizations
- Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development

About us

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. Thermo Fisher Scientific Australia is an WGEA Employer of Choice for Gender Equality.

📌 Clinical Research Associate (Level I or II) (Melbourne)
🏢 Thermo Fisher Scientific Australia
📍 Melbourne