Clinical Trial Coordinator (ANZ) - FSP at Thermo Fisher Scientific

Auckland, Auckland, New Zealand

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree in health science field
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience
Ability to work in a team or independently as required
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
Good English language and grammar skills and proficient local language skills as needed
Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Effective oral and written communication skills
Crucial judgment and decision-making

Responsibilities

Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s)
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads
Provides system support (i.e., Activate & eTMF) and ensures system databases are always current
Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members
May support scheduling of client and/or internal meetings
May review and track of local regulatory documents
Maintains vendor trackers
Supports start-up team in Regulatory submissions
Works directly with sites to obtain documents related to site selection
Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks
Support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document
Aid the development of the critical path for site activation within assigned projects in support of rapid site activations

Skills

Key technologies and capabilities for this role

Clinical TrialsStudy CoordinationAdministrative SupportFile ReviewAudit ReadinessSOP ComplianceSite Activation

Questions & Answers

Common questions about this position

Is this a remote position?

Yes, this is a home-based position, preferably based in Auckland, Melbourne, Sydney, or Brisbane.

What are the key responsibilities of a Clinical Trial Coordinator?

Responsibilities include performing file reviews, ensuring tasks are on time and within budget, providing system support like Activate & eTMF, administrative tasks such as document processing and mass mailings, supporting regulatory submissions, and working with sites and teams.

What education is required for this role?

A Bachelor's degree is required, though the specific field is not fully specified in the description.

What is the work schedule for this position?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What makes a strong candidate for this Clinical Trial Coordinator role?

Strong candidates demonstrate determination to deliver quality and accuracy, proactive communication of risks, ability to work collaboratively with teams and sites, and support for rapid site activations and audit readiness.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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