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About the Role
Thermo Fisher Scientific is dedicated to enabling customers to make the world healthier, cleaner, and safer. We provide teams with resources for career goals and advancing science through research, development, and delivery of life-changing therapies. Our work spans laboratory, digital, and decentralized clinical trial services, aiming to improve health outcomes for people and communities.
Responsibilities
- Monitors investigator sites using a risk-based approach, applying root cause analysis and problem-solving skills to identify process failures and implement corrective actions.
- Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring.
- Assesses investigational product through physical inventory and records review.
- Documents observations in reports and letters using approved business writing standards.
- Escalates deficiencies and issues to clinical management and follows them through to resolution.
- Maintains regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
- Conducts supervising tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures shared responsibility with project team members for issue resolution.
- Investigates and follows up on findings.
- Participates in investigator meetings as needed.
- Identifies potential investigators in collaboration with the client company.
- Initiates clinical trial sites according to procedures to ensure compliance with protocol and regulatory obligations.
- Performs trial close out and retrieval of trial materials.
- Ensures required crucial documents are complete and in place according to ICH-GCP and applicable regulations.
- Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager.
- Ensures study systems are updated per agreed study conventions.
- Facilitates effective communication between investigative sites, the client company, and the PPD project team.
- Responds to company, client, and regulatory requirements, audits, and inspections.
- Maintains and completes administrative tasks such as expense reports and timesheets.
- Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas.
- Contributes to other project work and initiatives for process improvement.
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.
- Experience in Cell and Gene Therapy (CGT) is mandatory.
- Australian citizenship or permanent residency required.
Skills
- Proven clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations, and procedural documents.
- Well-developed critical thinking skills, including 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.
- Ability to communicate effectively with medical personnel.
- Ability to maintain customer focus through good listening skills, attention to detail, and ability to perceive customers’ underlying issues.
- Good organizational and time management skills.
- Effective interpersonal skills.
- Attention to detail.
- Ability to remain flexible and adaptable.
- Ability to work in a team or independently.
- Good digital literacy: solid knowledge of Microsoft Office and ability to learn appropriate software.
- Good English language and grammar skills.
- Good presentation skills.
Location
- Home-based
- Sydney
- Melbourne
Work Type
- Standard (Mon-Fri)
- Office
Experience Level
- Minimum one year of experience as a Clinical Research Monitor
Education Level
- Bachelor's degree in a life sciences-related field
- Registered Nursing qualification
- Equivalent relevant academic or vocational qualification
Salary/Compensations
- Competitive remuneration
- Annual incentive plan bonus
Benefits
- Comprehensive benefits
- Wellness programs
- Employee Assistance Program
- 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
- Mentorship programs
About the Company
- Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality
- Innovative, forward-thinking organization
- Outstanding career and development prospects
- Exciting company culture that stands for integrity, intensity, involvement, and innovation!
Equal Opportunity
- WGEA Employer of Choice for Gender Equality