[Remote] Sr. Clinical Trial Coordinator at Thermo Fisher Scientific

Mexico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree or previous experience comparable to 3 to 5 years

Responsibilities

Performs file reviews and documents findings in appropriate system, including supervising local regulatory documents
Supports maintenance of study-specific documentation and global systems/tools
Analyzes and reconciles study metrics and findings reports, clarifying and resolving issues related to site documentation
May support study-specific translation of materials and QC
Ensures efficient site contact and follow-up plan, bringing up concerns as needed
May work with the CTT Representative to provide relevant study information
May conduct quarterly eTMF completeness checks
Provides admin and technical support to study management and program teams, including supporting meeting scheduling, minute taking, document creation and transmission
May maintain vendor trackers
Works with sites to acquire relevant documents
Completes site interest plan and documents site communications
Works directly with sites to acquire site qualification, selection and start-up documents
Works with the CSO function to develop the site list and ensures contact details are maintained in systems including Veeva
Performs document processing and follow-up tasks, including initial quality checks of eTMF documents, file reviews, and documents findings
Requests eTraining report reviews to begin on a quarterly basis
Coordinates and completes assigned activities ensuring proactive scheduling and fulfillment, aligned with project team needs, including providing system access (e.g., Veeva & eTMF) and inputting site and study information into current databases and generating reports
Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and supplies to sites
Assists with Study Start-up and ongoing submission activities as needed, including transmitting documents to centralized IRB/IEC (ongoing), requesting insurance in each country, coordinating with key QSDO functions to align site start-up activities, coordinating the translation of study documents, and may help with checking if CDAs exist/are expired & acquiring a new Inv/Institution CDA
Supports survey data review and collaboration with teammates
May liaise and contribute to feasibility processes
Aligned with general and study specific training, ensuring knowledge of relevant SOPs and regulatory guidance
Contributes to the development of guidelines

Skills

eTMF

Veeva

clinical trial documentation

file reviews

study metrics

regulatory documents

site qualification

document processing

quality checks

vendor trackers

meeting scheduling

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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