[Remote] Clinical Trial Coordinator at Thermo Fisher Scientific

Argentina

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided
Utilizes local knowledge to contribute to the identification and development of new sites
May act as the local expert regarding site capacity and experience

Responsibilities

Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix
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 timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, providing documents and reports to internal team members
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 non-clinical study supplies to sites
Assists with study-specific translation materials and translation QC upon request
May support scheduling of client and/or internal meetings
May review and track local regulatory documents
May support RBM activities
May support the maintenance of study specific documentation and systems, including study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans
Transmits documents to client and centralized IRB/IEC
Maintains vendor trackers
Supports start-up team in Regulatory submissions
Works directly with sites to obtain documents related to site selection
Assists the project team with the preparation of regulatory compliance review packages
Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned
May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel
Documents in real time all communication, attempts and follow up associated with site contact and survey responses
Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked
Works in collaboration with teammates to achieve targeted deadlines for assigned projects
Communicates with the team and appropriate clinical personnel regarding site issues and risks
Ensures an efficient, effective plan is in place for site contact and follow up; ensures compliance with the plan and escalates concerns/non-compliance to management
Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information
Contributes to the development and roll-out of global strategic feasibility processes and best practices
Trains new personnel in processes and systems

Skills

Key technologies and capabilities for this role

eTMFActivateISFSOPsRegulatory SubmissionsIRB/IECStudy MetricsVendor TrackingDocument ManagementProject CoordinationAdministrative TasksSystem SupportRBM Activities

Questions & Answers

Common questions about this position

What is the work schedule for the Clinical Trial Coordinator role?

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

What are the main responsibilities of this position?

The role involves coordinating and completing trial activities on time and within budget, performing administrative tasks like document processing and eTMF reviews, analyzing study metrics, assisting with site files and regulatory submissions, and supporting site contact and team collaboration.

What skills or knowledge are required for this job?

Candidates need knowledge of SOPs, client directives, and regulatory guidelines, proficiency in systems like Activate and eTMF, strong organizational skills for administrative tasks and metrics analysis, and the ability to collaborate with teams and sites.

Is this a remote position?

This information is not specified in the job description beyond indicating an office environment.

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

A strong candidate excels in proactive communication of risks, ensuring high-quality task completion within timelines and budgets, system support proficiency, regulatory knowledge, and collaborative teamwork with sites and internal departments.

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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