[Remote] Clinical Trial Coordinator at Thermo Fisher Scientific

Argentina

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Knowledge of and understanding of SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided
Ability to use local knowledge, organization systems, external site lists, and sponsor directives
Proficiency in system support (e.g., Activate & eTMF)
Capability to act as a buddy during onboarding and provide training to new staff as needed

Responsibilities

Provides administrative and technical support to the Project Team
Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document
Provides administrative support for site activation activities
Aids the development of the critical path for site activation within assigned projects in support of rapid site activations
Represents CRG personnel
Develops and reviews site lists suitable for feasibility activities and provides local input into the site tiering process
Ensures allocated tasks are performed on time, within budget, and to a high-quality standard; proactively communicates any risks to project leads
Performs administrative tasks on assigned trials, including timely processing of documents to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, and providing documents and reports to internal team members
Provides system support (e.g., Activate & eTMF) and ensures system databases are always current
Analyzes and reconciles study metrics and findings reports; assists with clarification and resolution of findings related to site documentation
Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and nonclinical study supplies to sites
Assists with study-specific translation materials and translation QC upon request
Supports scheduling of client and/or internal meetings
Reviews and tracks local regulatory documents
Supports RBM activities
Supports the maintenance of study-specific documentation and systems, including study team lists, tracking of project-specific training requirements, system access management, and activity plans
Maintains vendor trackers; transmits documents to client and centralized IRB/IEC
Supports start-up team in Regulatory submissions
Assists the project team with the preparation of regulatory compliance review packages
Provides support to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned

Skills

Key technologies and capabilities for this role

Clinical TrialsSite ActivationAudit ReadinessProject CoordinationSOP ComplianceFeasibility StudiesAdministrative SupportCRG Systems

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This is an office-based position with standard Monday-Friday hours.

What are the key responsibilities of the Clinical Trial Coordinator?

The role involves providing administrative and technical support to the Project Team, ensuring audit readiness, supporting site activation activities, performing administrative tasks like eTMF reviews and document processing, and maintaining system databases.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work that positively impacts global health, provides resources for career goals, and focuses on enabling customers to make the world healthier, cleaner, and safer through clinical research.

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

Strong candidates demonstrate determination to deliver quality and accuracy, proactive communication of risks, ability to perform tasks on time and within budget, and familiarity with SOPs, clinical trial systems like Activate & eTMF, and site activation processes.

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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